Cleared Traditional

FibroLux

K212189 · Multi Radiance Medical · Physical Medicine

Sep 2022

Decision

416d

Days

Class 2

Risk

About This 510(k) Submission

K212189 is an FDA 510(k) clearance for the FibroLux, a Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (Class II — Special Controls, product code NHN), submitted by Multi Radiance Medical (Solon, US). The FDA issued a Cleared decision on September 2, 2022, 416 days after receiving the submission on July 13, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K212189 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2021
Decision Date	September 02, 2022
Days to Decision	416 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	NHN — Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5500
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. This Device Emits Energy In The Infrared Or Other Wavelengths, Provides Non-heating And Non-thermal Effect, And Is Indicated For Adjunctive Use In Pain Therapy Or Related Indication. It Does Not Provide Therapeutic Topical Heating. The Classification Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use.