Regulatory Guide

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

πŸ“’

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.

πŸ›‘οΈ

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.

πŸ“‹

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 restrictionsβ€”anyone 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 guidelineβ€”always verify current regulations.

Category 1

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
Category 2

Moderate Restrictions

  • Physician oversight is required
  • Medical Doctors may delegate to non-medical professionals
  • Delegation under individual state license
  • Specific supervision requirements vary
Category 3

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 1

Class 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 1

Class 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 Rules

Class 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 1

Class 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 Rules

Class 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 Rules

Class 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.

🐴 Equine: Only licensed veterinarians can use a laser on horses as part of a business.

Connecticut

Category 2 Additional Rules

Class 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 Rules

Class 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 Rules

Class 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 1

Class 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 Rules

Class 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 1

Class 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 Rules

Class 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 Rules

Class 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 Rules

Class 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 1

Class 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 Locally

Class 3 & 4 (Human): No specific information available. Please contact your state licensing board to verify current requirements.

Louisiana

Category 1

Class 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 3

Class 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 2

Class 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 3

Class 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 1

Class 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 1

Class 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 1

Class 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 1

Class 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 2

Class 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 2

Class 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 1

Class 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 2

Class 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 Restrictive

Class 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 Rules

Class 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 Established

Class 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 Restrictive

Class 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 Rules

Class 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 Rules

Class 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 Rules

Class 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 1

Class 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 2

Class 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 1

Class 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 1

Class 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 2

Class 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 2

Class 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 Rules

Class 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.

🐴 Equine: Only licensed veterinarians can use a laser on horses as part of a business.

Utah

Category 2

Class 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 1

Class 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 2

Class 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 Rules

Class 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 1

Class 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 1

Class 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 1

Class 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.

🍁 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 mandatedβ€”each 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.