FibroLux
510(k) K212189
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212189 | Date2 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K212189
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NHN
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The FibroLux is a Powered Light-Based Laser Non-Thermal Instrument designed for adjunctive use in pain therapy, delivering non-heating, low-level laser energy to target tissues. Classified as a Class II medical device, it is intended to provide temporary relief of pain associated with fibromyalgia and other musculoskeletal conditions. Its mechanism relies on photobiomodulation to stimulate cellular repair and reduce inflammation without thermal effects. The device operates within regulatory parameters defined by the FDA’s 510(k) clearance under the Physical Medicine advisory committee.
The FibroLux is supplied as a single-use or reusable device (depending on model variant), requiring no sterilization beyond manufacturer guidelines. It is non-MRI-safe and must be stored in a dry, temperature-controlled environment per instructions. Authorized for use in clinical settings such as physical therapy, orthopedic offices, and outpatient clinics, it adheres to FDA regulation 890.5500 and carries registration numbers listed under OpenFDA (e.g., 3011258423). No additional regulatory markings (e.g., CE marking) are referenced in the submitted data.
From the manufacturer
The FibroLux is the first and only therapeutic laser to be cleared by the FDA for adjunctive use in providing temporary relief of pain associated with fibromyalgia.
Multi Radiance Medical has remained dedicated to advancing cutting-edge medical solutions for over 15 years, and FibroLux exemplifies their commitment to providing effective, non-invasive, and clinically proven therapies that empower individuals to reclaim an active and pain-free lifestyle.
Devices cleared under K212189
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| FibroLux | 600-501 / FibroLux | 00852556007008 | — | On the market |
Similar devices
Other devices filed under FDA product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy).
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