Cold Laser Business Regulations
State-by-state requirements for therapy laser clinics
Important Legal Disclaimer
This information is provided for general reference only and may not be current. Regulations change frequently and this guide may not reflect the latest requirements. ColdLasers.org assumes no responsibility for the accuracy, completeness, or timeliness of this information.
- Always verify current regulations with your state licensing board
- Consult with a healthcare attorney before starting a laser therapy business
- Check with your insurance provider for coverage requirements
- Contact us if you have updated information we should include
Last reviewed: 2024 β Use at your own risk
Understanding the Three Types of Limitations
1. Advertising Limitations
The FDA regulates advertising of laser therapy devices. They can only be advertised for FDA-cleared applications: pain reduction, inflammation reduction, and increasing blood flow. Advertising for other applications carries regulatory risk.
2. Insurance Limitations
Any laser therapy business should carry liability insurance. Some insurance companies only allow the use of FDA-cleared devices on humans. Always verify coverage requirements with your insurance agent before purchasing equipment.
3. Local Regulations
Many states (and some professions) have additional limitations on who can use a laser, what records must be kept, and requirements for human and animal patients. These are detailed by state below.
Federal (FDA) Requirements
Laser Sales Requirements
Class 1 & 2: Over-the-counter (OTC) with no restrictionsβanyone can purchase.
Class 3 & 4: Can be sold to any healthcare practitioner. Can be sold for home use with a recommendation from a healthcare practitioner. Many manufacturers have a physician on staff who provides letters for compliance (often included in price).
Advertising Requirements
No one can advertise services using a cold laser for applications not related to pain control, inflammation control, or increasing blood flow. Misrepresentation can result in fines or license revocation.
Class 4 Laser Regulation Categories
States fall into three main categories for Class 4 laser requirements. Use this as a general guidelineβalways verify current regulations.
Least Restrictive
- Physician oversight not required
- Non-medical personnel may own clinic
- Medical Director may or may not be on-site
- Laser therapy may be provided by non-medical personnel
Moderate Restrictions
- Physician oversight is required
- Medical Doctors may delegate to non-medical professionals
- Delegation under individual state license
- Specific supervision requirements vary
Most Restrictive
- Only Medical Doctors may provide treatments
- May delegate to PA, RN, or other MD
- Specific exceptions may apply per state
- Additional rules often apply
Alabama
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Alaska
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Arizona
Category 1 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic and provide treatments. Medical Director (healthcare practitioner) required but not on-site. State requirements for training/certification regulated by Arizona State Board of Radiation.
Arkansas
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
California
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Laser therapy must be supervised by a Medical Doctor (not required on-site). Medical Director may supervise treatment but acts under MD supervision. Other healthcare practitioners may provide treatments under Medical Director who acts under MD supervision.
Colorado
Category 1 Additional RulesClass 3 (Human): Same as Class 4 below
Class 4 (Human): Non-medical professionals may own clinic and provide treatments. Medical Director (healthcare practitioner) required but not on-site. LSO recommended. Colorado has revised standards under Rule 800; training/certification supervised by Department of Higher Education, Health Occupations.
π΄ Equine: Only licensed veterinarians can use a laser on horses as part of a business.
Connecticut
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Only medical doctors may delegate non-medical professionals under their state license. Delegating physician responsible for Medical Director actions and must provide adequate supervision (direct or indirect, on-site or off-site at physician's discretion). PT, RN, LPN, EMT, etc. must work directly under medical doctor supervision; Medical Director must be on-site.
Delaware
Category 3 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Only medical doctors may delegate non-medical professionals under their state license. Physician responsible for activities and must provide adequate supervision (direct or indirect at physician's discretion). Physician must personally evaluate patient at least every three months.
Florida
Category 3 Additional RulesClass 3 (Human): System must be registered with the state
Class 4 (Human): Only medical doctors may delegate non-medical professionals. PT, RN, LPN, EMT, etc. must work under MD supervision; Medical Director must be on-site. Exception: Non-medical licensed Electrologists may own clinic and provide treatments with Medical Director supervision (not on-site). Medical doctor must be within 30 minutes and available to respond. Training supervised by Florida State Electrology Association.
Georgia
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Hawaii
Category 3 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Physicians may delegate non-medical professionals under their state license. PT, RN, LPN, EMT, etc. must work under MD supervision; Medical Director must be on-site. Note: Maui is exempt from this rule.
Idaho
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Illinois
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Laser therapy MAY be supervised by MD (not on-site). Medical Director must be licensed healthcare practitioner. PT, PA, RN, LPN, massage therapist, or certified laser therapy technician may provide treatments under Medical Director supervision.
Indiana
Category 3 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Physicians may delegate non-medical professionals under their state license. PT, RN, LPN, EMT, etc. must work directly under MD supervision; Medical Director must be on-site.
Iowa
Category 3 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Physicians, RNs, PAs, plus Electrologists, Aestheticians, and Cosmetologists may provide treatments and delegate trained/certified non-medical professionals. Medical Director required (must be Healthcare Practitioner). Supervision direct or indirect, on-site or off-site at physician's discretion.
Kansas
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Kentucky
Verify LocallyClass 3 & 4 (Human): No specific information available. Please contact your state licensing board to verify current requirements.
Louisiana
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Maine
Category 3Class 3 (Human): No additional restrictions
Class 4 (Human): Physicians can delegate PA or RN under their state license. Medical Director required (must be Healthcare Practitioner). Supervision direct or indirect, on-site or off-site at physician's discretion.
Maryland
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Physicians, PAs, and RNs can delegate trained/certified non-medical professionals (laser therapy technicians) under their state license. Physician, PA, or RN responsible for activities and must provide supervision (direct or indirect at their discretion).
Massachusetts
Category 3Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic, but laser therapy must be provided directly by a physician OR by medical professional operating under physician's direct supervision. Physician determines on-site requirements.
Michigan
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Minnesota
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Mississippi
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Missouri
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Montana
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Physicians, PAs, and RNs can delegate trained/certified non-medical professionals. Medical Director required (Physician, PA, or RN). Supervision direct or indirect at their discretion. Medical Director must be on-site.
Nebraska
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Nevada
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
New Hampshire
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Physicians can delegate to trained/certified non-medical professionals. Medical Director required; all operate under Physician's license. Medical Director must be on-site.
New Jersey
Category 3 Highly RestrictiveClass 3 (Human): No additional restrictions
Class 4 (Human): Only Medical Doctor (MD) or Doctor of Orthopedic Medicine may provide laser therapy treatments.
New Mexico
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Physicians, PAs, RNs can delegate to Certified Laser Therapy Technicians, Cosmetic Therapists, or Electrologists. Medical Director required (Physician, PA, or RN). Medical Director must be on-site.
New York
No Rules EstablishedClass 3 (Human): No additional restrictions
Class 4 (Human): No Class 4 laser therapy regulations have been written by New York to date. Non-medical professionals may own clinics and provide Class 4 laser therapy. Medical Director or physician supervision is not required.
North Carolina
Category 3 Highly RestrictiveClass 3 (Human): No additional restrictions
Class 4 (Human): Only Medical Doctor (MD) or Doctor of Orthopedic Medicine may provide laser therapy treatments.
North Dakota
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Ohio
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Physicians, PAs, RNs can delegate to Certified Laser Therapy Technicians, Cosmetic Therapists, or Electrologists. Medical Director required. Medical Director may or may not be on-site.
Oklahoma
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Oregon
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Pennsylvania
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Rhode Island
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
South Carolina
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
South Dakota
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Only Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Tennessee
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Only Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director. Exception: Electrologists can provide laser treatments without Physician supervision.
Texas
Category 1 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic and provide treatments. Medical Director (healthcare practitioner) required but not on-site. LSO recommended. State certificate required for laser electrolysis procedures; must be supervised by Medical Director.
π΄ Equine: Only licensed veterinarians can use a laser on horses as part of a business.
Utah
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Physician oversight required. Only Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Vermont
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Virginia
Category 2Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Physician oversight required. Only Physicians can delegate to trained/certified non-medical professionals. Physician is de facto Medical Director and makes all treatment decisions.
Washington
Category 2 Additional RulesClass 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own clinic. Only Physicians, PAs, Doctors of Naturopathic Medicine, or Licensed Aestheticians can operate the laser. Physician or PA must oversee consultation and treatment. PA can delegate to certified personnel. PA must be on-site.
Training Requirement: State requires laser operators to get 6 hours of training and certificate from the laser manufacturer.
West Virginia
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Wisconsin
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
Wyoming
Category 1Class 3 (Human): No additional restrictions
Class 4 (Human): Non-medical professionals may own a Class 4 laser therapy clinic and provide treatments. Supervision by assigned Medical Director (Health Care Practitioner) who does not need to be on-site. LSO recommended. All personnel should be trained and certified.
π Canada Requirements
Any professional using a laser to treat humans in Canada must use a laser that is Health Canada approved.
Health Canada Approved Options We Carry:
- Apollo Desktop and Portable Systems
- TerraQuant Lasers
Key Definitions
Medical Director
Licensed Health Care Practitioner (MD, PT, Chiropractor, RN, LPN, PA, Veterinarian, Acupuncturist, etc.) with specialized training and certification in Class 4 laser operation. Certification typically completed through manufacturer, authorized distributor, or certified trainer.
Laser Safety Officer (LSO)
Person responsible for knowing and implementing laser safety practices in the clinic, with oversight over safe ownership and use of Class 4 lasers in medical or veterinary settings.
Training & Certification
The Medical Director determines laser usage and trains/certifies technicians. Laser Therapy Technicians work under Medical Director supervision. Training can be provided by manufacturer, distributor, or certified trainer.
Health Care Practitioner
Individual providing preventive, curative, promotional, or rehabilitative health care. Includes Physicians, Dentists, PAs, Nurses, Physical Therapists, Chiropractors, Massage Therapists, Optometrists, and many other licensed practitioners.
Supervision
Practitioners must work under Medical Director or physician supervision (unless otherwise noted). Direct supervision is not always mandatedβeach state may deviate. Non-medical professionals may own clinics providing Class 4 therapy in many states.
Questions About Regulations?
We can help you understand requirements for your state and practice type. Call us for guidance on compliance and equipment selection.