Description
This draft guidance document provides the FDA’s recommendations on non-clinical testing, clinical studies, and labeling to support premarket submissions for photobiomodulation (PBM) devices, also known as low level light therapy (LLLT) devices. This guidance applies to class II PBM medical devices regulated under 21 CFR 878.4810, 878.4850, 878.5400, and 890.5500. This guidance also applies to the PBM component of devices that combine a PBM device with another device(s) (e.g., electrostimulation source, mechanical massager, or ultrasound). Some light-emitting products that are intended for only general wellness use and present a low risk to the safety of users and other persons, may not be within the scope of this guidance. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of PBM device submissions.
Scope & Applicability
Product Classes
2The primary subject of the guidance, also known as low level light therapy (LLLT) devices.; Subject of the guidance document; Subject of the guidance document regarding premarket notification submissions.; Subject of the premarket notification guidance; examples of warnings and precautions for PBM devices
Specific category of PBM devices with unique performance testing requirements.
Stakeholders
4Guidance for Industry
Way questions are framed is critical to collecting unbiased patient input
Entity responsible for submitting NDINs
Intended user population for emergency use auto-injectors
Regulatory Context
Attributes
7Radiant dose parameter for device description.; Radiant dose delivered to tissue
Dose selection parameter defined as light energy received per unit area
Factor impacting dose selection in clinical studies
Classification of skin types used to assess treatment-emergent risks.
Categorization (minor, moderate, major) for software risk.
Light generation parameter for device description.; Technical parameter in nanometers
Radiant power parameter for device description.; Radiant power per area; Dose selection parameter defined as light power received per unit area
Identified Hazards
Hazards
7Safety concern regarding heat generation.
To eliminate any possible danger to the eyes
Risk posed by energy and irradiance values greater than maximum permissible exposure.
Risk caused by inadvertent overuse or high irradiance leading to thermal injury.; Misuse of the device might lead to injury
Potential risk for medical electrical equipment failing to operate properly.
Safety concern regarding light exposure to the eyes.
Warning against use of non-thermal lasers over these areas
Related CFR Sections (8)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR878.4860§ 878.4860 Light based energy source device for topical application.
(a) Identification. The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR878.4810§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a) Identification.Read full regulation →
- 21CFR878.5400§ 878.5400 Low level laser system for aesthetic use
(a) Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.Read full regulation →
- 21CFR890.5500§ 890.5500 Infrared lamp.
(a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.Read full regulation →
- 21CFR1040.20§ 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a) Applicability.Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
Related Warning Letters (10)
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Uscom Kft
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Visgeneer, Inc
- 2025-07-29
CGMP/QSR/Medical Devices/Adulterated
Onkos Surgical, Inc.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-04-01
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Next Science LLC
See Also (8)
- Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- General/Specific Intended Use - Guidance for Industry (Status: Final)
- Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)