Professional practice
Published on
June 6, 2025
Photobiomodulation: What Does French Law Say? Devices, Requirements, and Guidelines for Use
In short: The use of photobiomodulation depends on the practitioner’s status, the country, and the device. In France, it is a therapeutic procedure that doctors may perform freely, one that is regulated for physical therapists, but prohibited for estheticians and naturopaths without medical supervision. The devices must be CE-marked medical devices registered with the ANSM. Liability insurance, informed consent, and the ability to track treatment sessions are also required.
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 can be performed without restriction
- Physical Therapist: Conditions 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 Physicians: 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, and 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
Conditions Eligible for Reimbursement
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
- Implementing PBM in a medical practice
- device safety standards
- Precautions and Professional Environment
- check for contraindications
Scientific sources
- Robijns et al. (2022). Photobiomodulation therapy in the management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. Read on PubMed
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