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FibroLux

by Multi Radiance Medical

FibroLux (600-501) is a Class II device made by Multi Radiance Medical, cleared under FDA 510(k) K212189 on 2 Sep 2022 and listed in FDA GUDID since 8 Nov 2022 (UDI-DI 00852556007008), active as of 21 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K212189

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852556007008 UDI-DI Date8 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212189 Date2 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212189 decided 2 Sep 2022 Active
  • FDA GUDID UDI-DI 00852556007008 listed 8 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212189
  2. Listed FDA GUDID 00852556007008

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / Ref / Catalog
FibroLux, 600-501
Primary DI / UDI-DI
00852556007008
510(k) Number
FDA product code
NHN
GMDN term
Musculoskeletal infrared phototherapy unit, non-wearable
Device class
Class II
Regulation number
890.5500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Musculoskeletal infrared phototherapy unit, non-wearable

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).

Other devices from Multi Radiance Medical

See all devices from Multi Radiance Medical →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)