Following is a summary of the state by state and special regulations for using therapy lasers in a business. This resource is NOT 100% complete as rules, laws and regulations do change periodically, and keeping up with them constantly is unrealistic for us. If you are purchasing a laser to use in your practice it is advisable to check your local regulatory agencies to confirm that there are no further regulations. If you know of a regional requirement that we have not listed here, please send us the information so we can keep this reference up to date, which will help everyone. Discover Lasers LLC and and its agents assume no responsibility or liability for the accuracy of this information. Use it at your own risk.

There are 3 primary 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. Insurance Limitation: Any laser therapy business should have insurance in case someone sues the business. Some insurance 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:

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

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).

US LLLT Requirement by State

If you are interested in LLLT for animal and Equine applications, here is a very good resources for Veterinary regulations by state.




























New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota





Rhode Island

South Carolina

South Dakota







West Virginia



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 certified 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.

Canada Requirements for Therapy Lasers

Human Use: Any professional using a laser to treat humans in their practice in Canada must use a laser that is Health Canada approved. The options that we sell that are Health Canada approved are: