# K212189: FibroLux

- Pathway: 510(k) (Traditional)
- Applicant: Multi Radiance Medical
- Decided: Sep 2, 2022 after 416 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K254024: MR5 Activ Pro (2026), 0 descendants of its own

## Indications for use
The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.

Source page: https://510kreport.com/device/K212189
Methodology: https://510kreport.com/methodology