Photobiomodulation: What Does French Law Say? Devices, Requirements, and Guidelines for Use

The use of photobiomodulation is governed by several regulatory provisions, depending on the practitioner’s status, geographic location, and the type of device used.

In France

Medical status

• Doctor: PBM is considered a therapeutic procedure and may be performed without restriction
• Physical Therapist: Services covered underArticle L4321-1 of the Public Health Code (pain, inflammation)
• Esthetician: PROHIBITED (classified as a non-delegated medical procedure)
• Naturopath / Wellness: PROHIBITED without medical supervision

Approved devices

• Class II or III medical devices (CE marking required)
• A detailed technical dossier is required from the ANSM
• Evidence of clinical efficacy for certain indications

In Europe

European Union

• Germany: Regulated as a medical device (Federal Law Gazette I, 2015, p. 3115)
• Belgium: Licenses for physical therapists and physicians
• Switzerland: Not classified as a drug (LAMal), licensing available for practitioners
• Italy: Approved for use by physicians and physical therapists
• Spain: Supervision by the Order of Physical Therapists

In the United States and Canada

United States

• The FDA regulates LLLT/PBM devices
• Class II Devices (510(k) clearance): Commonly Used in Clinics
• Unregulated "wellness" devices (legally less clearly defined)
• Doctors, therapists, and beauty salons can use it (vague guidelines)

Canada

• Regulated by Health Canada (Therapeutic Products Directorate)
• Devices approved for therapeutic use
• Physical therapists and doctors: common practice

Liability and Insurance Coverage

• Professional Liability Insurance: Mandatory in France for Healthcare Professionals
• Informed Consent: Essential (the patient must be aware of the effects, limitations, and risks)
• Documentation: Record each session (device used, power, duration, indication)
• Contraindications: check for cancer, epilepsy, pregnancy

Recommendations for practitioners

• Earn a degree or recognized certification in PBM
• Register with theprofessional association (CNOM, Order of Physical Therapy, etc.)
• Ensure that equipment complies with ISO standards (ISO 60601 for medical devices)
• Maintenanceof a "patina" registry and informed consent
• Establish an incident reporting procedure to the ANSM

Reimbursable conditions

Currently, this treatment is NOT covered by health insurance in France. Pending:

• Complete ANSM dossier and approval
• More extensive clinical evidence (HAS criteria)
• Advocacy with Améli

See also

• PBM and pain: medical supervision
• PBM and Pregnancy: Safety Considerations