FibroLux

Q: When was FibroLux cleared by the FDA?

FibroLux (K212189) received a 510(k) decision of Substantially Equivalent on September 2, 2022, 416 days after the submission was received.

Q: What is the product code of K212189?

The FDA product code is NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, a Class II (moderate risk) device regulated under 21 CFR 890.5500.

FDA 510(k) K212189 · Multi Radiance Medical

Substantially Equivalent

510(k) numberK212189

Submission

Device name: FibroLux
Applicant: Multi Radiance Medical
Solon, OH, US
Received: July 13, 2021
Decision date: September 2, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

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 (moderate risk)
Regulation: 21 CFR 890.5500
Specialty: Physical Medicine

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…

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K232813	Therapy EC, Therapy XTNHN · Traditional	Dmc Importacao E Exportacao DE Equipamentos Ltda	12/19/2024SE
K231409	Erchonia FX-405NHN · Traditional	Erchonia Corporation	08/11/2023SE
K221987	Erchonia GVLNHN · Traditional	Erchonia Corporation	09/01/2022SE
K203337	PainTB, PainTJNHN · Traditional	Ptech Co., Ltd.	02/11/2022SE
K212595	Erchonia FX-405NHN · Traditional	Erchonia Corporation	11/12/2021SE
K211186	Erchonia XLR8NHN · Traditional	Erchonia Corporation	10/22/2021SE

More from Erchonia Corporation

510(k)	Device	Decision
K254024	MR5 Activ ProNHN · Traditional	05/19/2026SE
K171354	MR4 LaserNHN · Traditional	01/13/2018SE

Questions and answers

When was FibroLux cleared by the FDA?

FibroLux (K212189) received a 510(k) decision of Substantially Equivalent on September 2, 2022, 416 days after the submission was received.

What is the product code of K212189?

The FDA product code is NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, a Class II (moderate risk) device regulated under 21 CFR 890.5500.