DOCUMENTS

Cold Laser Business Regulations and Regulations for LLLT Clinics

The page is a summary of the regional and special regulations for using therapy lasers in a business. This resource is not 100% complete so you must check your local regulatory agencies to confirm that there are not further regulations. If you know of a regional requirement, please send us information so we can keep this page up to date and help everyone. Coldlasers.Org assumes no responsibility for the accuracy of this information. Use it at your own risk.

In general, there are 3 types of limitation on laser therapy businesses:

  1. Advertising Limitations. The FDA regulates advertising of laser therapy devices. They can only be advertised for FDA cleared application. For lasers, this is pain reduction, inflammation reduction and increasing blood flow. There are lots of people advertising for other application and they are taking a risk that someone does not report them.
  2. Insurnace Limitation: Any laser therapy business should have insurance in case someone sues the business. Some insurnace companies only allow the use of FDA cleared devices on humans so everyone should check with their agent.
  3. Local regulation. Many state and some professions have addition limited about who can use a laser and what type of records must be kept for the care of humans. Some state also regulate the use of lasers on animals.

US Laser Therapy Requirements

There are several layers of regulations and requirement in the United States. At the national level, the 2 main requirement are on the sale and advertising of lasers:

  • Class 1 and 2 systems are OTC (over the counter) with no restrictions on anyone. Class 3 and 4 lasers can be SOLD to ANY health care practitioner4 and they can be sold for home use with a recommendation from a health care practitioner4. Many manufacturers have a doctor on staff who writes the letters to stay in compliance so and this is often included in the price. This requirement is on the manufacturer and not the buyer. Some legitimate international companies and most fly-by-night companies do not comply with this requirement.
  • No one can advertise for a service using a cold laser that is not related to pain control, inflammation control or increasing blood flow. Some one who is misrepresenting their health care service can be fined or loose their license.

US Regional Regulations for Businesses

In addition to the national FDA requirement, some states have created laws to support special interest groups, stifle competition and hold back usage of cold laser market. Many of the restriction on class 4 laser were lobbied for by class 1, 2 and 3 manufacturers that did not want the competition. Some regulations were created to make sure that only one small group can financially benefit from laser technology. These regulations will slow down the adoption and wider usage of lasers but compliance is critical component of every business. These regulations are based on the type of patient (human or animal) and the class of the laser.

Special Requirement for Class 4 Lasers


Class 4 lasers are the most restricted group of lasers. They have additional requirements in many states. The level of regulation can be be grouped into 3 basic categories. Use these categories, the list below and definition (below the table) as a general guideline to state-by-state special regulations.

Class 4 Laser – Category 1 State Requirements

  • Physician Oversight Not Required
  • Nonmedical Personnel May Own Clinic
  • Medical Director May or May Not Be On-Site
  • Laser therapy may be provided by nonmedical personnel
  • Class 4 Laser – Category 2 State Requirements

Physician Oversight Is Required? Medical Doctors May Delegate Non-medical Professionals under Their Individual State License to Provide Laser Therapy

Class 4 Laser- Category 3 State Requirements

Only Medical Doctors May Provide Laser Therapy Treatments (in some cases they may be able to delegate a Physician’s Assistant (PA), Registered Nurse (RN), or other Medical Doctor to provide treatments; some exceptions may apply according to specific state guidelines, additional rules may also apply).

Alabama
Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Alaska

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Arizona

Arizona has additional requirements on the use of laser that you can find here: https://azdhs.gov/licensing/radiation-regulatory
Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1, additional rules apply): Class 4 Human Patient Requirements: Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by a Medical Director who is a health care practitioner4 but does not need to be on-site, and treatments may be provided by other nonmedical professionals who are certified by the clinic’s Medical Director1. State requirements for appropriate training and certification are regulated by the Arizona State Board of Radiation.

Arkansas

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

California

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply): Non-medical professionals may own a Class 4 laser therapy clinic; laser therapy treatment must be supervised by a Medical Doctor who does not need to be on-site. The clinic’s Medical Director1 may supervise treatment, but acts under the supervision of the Medical Doctor. Other Health care Practitioners4 may provide laser therapy treatments under the supervision of the Medical Director1 who in turn acts under the supervision of the Medical Doctor.

Colorado

Class 3 Humans: Same as CLass 4 listed below
Class 4 Humans (Category 1, additional rules apply): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health care Practitioner and laser therapy treatments may be provided by other nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser. Â (Note: Colorado has revised their standards under Rule 800; state guidelines for appropriate training and certification are supervised by the Department of Higher Education, Health Occupations.)
Equine: Only licensed veterinarian can use a laser on horses as part of a business.

Connecticut

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply): Only medical doctors may delegate non-medical professionals under their individual state license to provide laser therapy. The delegating physician is responsible for actions of the Medical Director1 in the Clinic, and must provide adequate supervision. It is up to the physician whether the supervision is direct or indirect, and whether the physician is on-site or off-site. Other medical practitioners such as a PT, RN, LPN, EMT, etc. must work directly under the medical supervision and licensure of a medical doctor; the clinic’s Medical Director1 must be on site.

Delaware

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3, additional rules apply): Only medical doctors may delegate non-medical professionals under their individual state license; the physician is responsible for their activities and must provide adequate supervision. It is up to the physician whether the supervision is direct or non-direct. The physician must personally evaluate any patient at least every three months.

Florida

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3, additional rules apply): Only medical doctors may delegate non-medical professionals under their Florida license to provide laser therapy. The delegating physician is responsible for actions of the Medical Director in the Clinic, and must provide adequate supervision. It is up to the physician whether the supervision is direct or indirect, and whether the physician is on-site or off-site. Other medical practitioners such as a PT, RN, LPN, EMT, etc. may provide laser therapy treatments, but must work directly under the medical supervision and licensure of a medical doctor; the clinic’s Medical Director1 must be on site. Non-medical licensed Electrologists may own a Class 4 laser therapy clinic and provide laser therapy treatments in the state of Florida; supervision must be provided by a Medical Director1 who is a health care practitioner4 but does not need to be on-site, and treatments may be provided by other nonmedical professionals who are certified by the clinic’s Medical Director1. A medical doctor must be 30 minutes away or less, and must be available to respond to medical needs within a 30-minute window. State requirements for appropriate training are supervised by the Florida State Electrology Association. (Note: Electrology is the practice of electrical epilation to permanently remove human hair; the process of removing the hair is referred to as electrolysis.)

Georgia

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Hawaii

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3, additional rules apply): Physicians may delegate non-medical professionals under their individual state license to provide laser therapy. The delegating physician is responsible for actions of the Medical Director1 in the Clinic, and must provide adequate supervision. It is up to the physician whether the supervision is direct or indirect, and whether the physician is on-site or off-site. Other medical practitioners such as a PT, RN, LPN, EMT, etc. must work directly under the medical supervision and licensure of a medical doctor; the clinic’s Medical Director1 must be on site. (Note: Maui is exempt from this rule.)

Idaho

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Illinois

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply) : Non-medical professionals may own a Class 4 laser therapy clinic; laser therapy treatment MAY be supervised by a medical doctor who does not need to be on-site. The clinic’s Medical Director, who must be a licensed health care practitioner4, supervises treatment. Other Health care Practitioners4, such as a PT, PA, RN, LPN, massage therapist, or certified laser therapy technician may provide laser therapy treatments and act under the supervision of the Medical Director1.

Indiana 

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3, additional rules apply): Physicians may delegate non-medical professionals under their individual state license to provide laser therapy. The delegating physician is responsible for actions of the Medical Director in the Clinic, and must provide adequate supervision. It is up to the physician whether the supervision is direct or indirect, and whether the physician is on-site or off-site. Other medical practitioners such as a PT, RN, LPN, EMT, etc. must work directly under the medical supervision and licensure of a medical doctor; the clinic’s Medical Director1 must be on site. (Note: Maui is

Iowa

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3, additional rules apply): Physicians, RNs, PAs, in addition to Electrologists, Aestheticians, and Cosmetologists, may provide laser therapy treatments, and delegate trained and certified3 non-medical professionals under their individual state licenses to provide laser therapy; a Medical Director1 is required and must be a Health care Practitioner4. The delegating physician is responsible for actions of those operating under their license, and must provide adequate supervision. It is up to the physician whether the supervision is direct or indirect, and whether the physician is on-site or off-site.

Kansas

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Louisiana

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Maine

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3): Physicians can delegate a PA or an RN under their individual state license to provide laser therapy; a Medical Director1 is required and must be a Health care Practitioner4. The delegating physician is responsible for actions of those operating under their license, and must provide adequate supervision. It is up to the physician whether the supervision is direct or indirect, and whether the physician is on-site or off-site.

Maryland

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Physicians, PAs, and RNs, can delegate trained and certified non-medical professionals such as laser therapy technicians under their individual state license to provide laser therapy; however the physician, PA, or RN responsible for their activities and must provide adequate supervision. It is up to the Physician, PA, or RN, whether the supervision is direct or non-direct.

Massachusetts

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3): Nonmedical professionals may own a laser therapy clinic, but laser therapy must be provided directly by a physician, or by a medical professional operating directly under a physician’s supervision. The physician dictates whether the supervision will be on-site.

Michigan

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Minnesota

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Mississippi

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Missouri

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Montana

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Physicians, PAs, and RNs can delegate trained and certified non-medical professionals under their individual state licenses to provide laser therapy; the physician, PA, or RN responsible for their activities and must provide adequate supervision. A Medical Director1 is required, and must be a Physician, PA, or RN. It is up to the Physician, PA, or RN whether the supervision is direct or indirect, and the Medical Director1 must be on-site.

Nebraska

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Non-medical professionals may on a Class 4 laser therapy clinic; Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.
Nevada

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

New Hampshire

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. A Medical Director1 is required; all operate under the Physician’s license and supervision. It is up to the Medical Director1 whether the supervision is direct or indirect, the Medical Director1 must be on-site.

New Jersey

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3): In New Jersey, a Medical Doctor or a Doctor of Orthopedic Medicine ONLY can provide laser therapy treatments.

New Mexico

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply): Physicians, PAs, and RNs can delegate trained and certified3 non-medical professionals such as Certified Laser Therapy Technicians, Cosmetic Therapists, or Electrologists under their individual state license to provide laser therapy; however, the physician, PA, or RN responsible for their activities and must provide adequate supervision. A Medical Director1 is required, and must be a Physician, PA, or RN. It is up to the Physician, PA, or RN whether the supervision is direct or indirect, and the Medical Director1 must be on-site.

New York

Class 3 Humans: No additional restrictions
Class 4 Humans (Category is open, has no rules are yet established): No Class 4 laser therapy regulations or guidelines have been written by the state of New York to date. Non-medical professionals may own Class 4 therapy laser clinics and provide Class 4 laser therapy. A Medical Director1 or physician is not required to supervise Class 4 laser therapy in the state of New York.

North Carolina

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 3): In North Carolina ONLY a Medical Doctor or a Doctor of Orthopedic Medicine can provide laser therapy treatments.

North Dakota

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply): Non-medical professionals may on a Class 4 laser therapy clinic; Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.

Ohio

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply): Physicians, PAs, and RNs can delegate trained and certified3 non-medical professionals such as Certified Laser Therapy Technicians, Cosmetic Therapists, or Electrologists under their individual state license to provide laser therapy; the physician, PA, or RN is responsible for their activities and must provide adequate supervision. A Medical Director1 is required, and must be a Physician, PA, or RN. It is up to the Physician, PA, or RN whether the supervision is direct or indirect, and the Medical Director1 may or may not be on-site.

Oklahoma

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2, additional rules apply): Non-medical professionals may own a Class 4 laser therapy clinic; Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.

Oregon

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Pennsylvania

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Non-medical professionals may own a Class 4 laser therapy clinic; Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.
Rhode Island

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

South Carolina

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.
South Dakota

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Non-medical professionals may own a Class 4 laser therapy clinic; only Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.

Tennessee

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Non-medical professionals may own a Class 4 laser therapy clinic; only Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it. Electrologists can provide laser treatments without Physician supervision.

Texas

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1; additional rules apply): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health care Practitioner4 and laser therapy treatments may be provided by other nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser. Â A State certificate is required for laser electrolysis procedures; all procedures must be supervised by the Medical Director1.
Equine: Only licensed veterinarian can use a laser on horses as part of a business.

Utah

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Non-medical professionals may own a Class 4 laser therapy clinic; physician oversight is required for laser therapy treatments. Only Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.

Vermont

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Virginia

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2): Non-medical professionals may on a Class 4 laser therapy clinic; physician oversight is required. Only Physicians can delegate nonmedical professionals to provide laser therapy as long as they are properly trained and certified3. The Physician is the de facto Medical Director1 and makes all decisions regarding laser therapy treatment and who provides it.

Washington

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 2; additional rules apply): Non-medical professionals may own Class 4 laser therapy clinic; however, only physicians, PAs Doctors of Naturopathic Medicine, or a Licensed Aesthetician can operate the laser. A Physician or Physician’s Assistant (PA) must oversee consultation and treatment, a PA can provide therapy laser treatments or delegate procedures to properly certified and trained nonmedical personnel, and must be on site.

West Virginia

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Wisconsin

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.

Wyoming

Class 3 Humans: No additional restrictions
Class 4 Humans (Category 1): Non-medical professionals may own a Class 4 laser therapy clinic and provide laser therapy treatments; supervision must be provided by an assigned Medical Director1 who should be a Health Care Practitioner4 and laser therapy treatments may be provided by nonmedical professionals under the supervision of the clinic’s Medical Director1 who does not need to be on-site. It is recommended that a Laser Safety Officer2 (LSO) be assigned to carry out LSO duties, and that all clinic personnel be trained and certified3 in the use of the laser.
Notes: The following terms are defined here because they are part of the regulations.

1 Medical Director: Clinics that offer laser therapy are required to have a Medical Director, who is a licensed Health Care Practitioner. The practitioner may be a Medical Doctor (MD), Physical Therapist, Chiropractor, Registered Nurse, Licensed Practical Nurse, Physician’s Assistant, Veterinarian, Head Veterinary Technician, Acupuncturist, or other Licensed Health Care Practitioner with a broad working knowledge of common health care practices and specialized training and certification in the operation and usage of a Class 4 laser. Laser Therapy Certification is completed by various means, usually through completion of a course offered by the laser manufacturer, authorized distributor, or by a certified laser therapy trainer.

2 Laser Safety Officer: Clinics that own and operate Class 4 therapy lasers in any kind of medical or veterinary setting must appoint a Laser Safety Officer (LSO), who is responsible for knowing and implementing established laser safety practices in the clinic, and has oversight over the safe ownership and use of the Class 4 laser.

3 Training and Certification: The MEDICAL DIRECTOR will determine how the laser is used in the clinic and train and/or certify medical/non-medical technicians in the safe and established use of the laser. Laser Therapy Technicians, trained and certified3 by the clinic’s MD (Medical Director), laser manufacturer, authorized distributor, or other certified laser trainer will work under the direct supervision of the clinic’s MEDICAL DIRECTOR. Please note that all necessary training and certification for the positions of Class 4 Laser Therapy Technician (LTT) and Class 4 Laser the Laser Safety Officer (LSO) can be provided).

4 Health Care Practitioner: A Health Professional, Health-Care Provider, or Health care Practitioner is an individual who provides preventive, curative, promotional, or rehabilitative health care, and may operate within medical, surgical, naturopathic medicine, dentistry, nursing, pharmacy, psychology, or other health professions. Health care practitioners include Physicians of All Types, Dentists, Orthodontists, Pharmacists, Physician Assistants, Nurses, Licensed Practical Nurses, Midwives and Other Licensed Holistic Practitioners, Anesthesiologists, Physical Therapists, Pathologists, Chiropractors, Clinical Social Workers, Clinical Psychologists, Phlebotomists, Occupational Therapists, Nurse Anesthetists, Respiratory Therapists, Speech Pathologists, Emergency Medical Technicians, Paramedics, Medical Laboratory Scientists, Medical Prosthetic Technicians, Massage Therapists, Optometrists, Holistic Practitioners, and a wide variety of other practitioners in the health care services industry.

5 Supervision: Laser therapy practitioners must work under the direct supervision of the clinics medical doctor OR other medical practitioner who is acting as the clinics Medical Director, unless otherwise noted in the state guidelines provided below. This does not necessarily indicate direct supervision is mandated; each state may deviate from other state supervisory standards as they determine, as national standards are not established other than those found in FDA 510K requirements. A non-medical professional or entrepreneur may own a clinic that provides Class 4 laser therapy in order to treat applicable medical conditions.

6 Implementation: A Medical Director who is certified in the use of Class 4 therapy lasers and is a licensed health care professional may provide laser therapy, or may, at their discretion, train and certify a PA, RN, PT, ND, other licensed health care practitioner or certified laser therapy technician to provide laser therapy treatments. Some states require a clinic’s Medical Director to act under the supervision of a medical doctor; the MD may or may not be on-site, and the supervision made direct or indirect, according to particular state regulations.

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