MR4 Laser

Q: When was MR4 Laser cleared by the FDA?

MR4 Laser (K171354) received a 510(k) decision of Substantially Equivalent on January 13, 2018, 249 days after the submission was received.

Q: What is the product code of K171354?

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) K171354 · Multi Radiance Medical

Substantially Equivalent

510(k) numberK171354

Submission

Device name: MR4 Laser
Applicant: Multi Radiance Medical
Solon, OH, US
Received: May 9, 2017
Decision date: January 13, 2018
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…

Other 510(k)s with product code NHN

510(k)	Device	Applicant	Decision
K254024	MR5 Activ ProNHN · Traditional	Multi Radiance Medical, Inc.	05/19/2026SE
K251903	Erchonia DPN Laser (Model# EVRL)NHN · Traditional	Erchonia Corporation	02/19/2026SE
K252273	Therapy USNHN · Traditional	Dmc Importação E Exportação DE Equipamentos Ltda	12/12/2025SE
K241057	Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)NHN · Traditional	Wuhan Guangdun Technology Co.,Ltd..	01/24/2025SE
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
K212189	FibroLuxNHN · Traditional	Multi Radiance Medical	09/02/2022SE
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

More from Erchonia Corporation

510(k)	Device	Decision
K254024	MR5 Activ ProNHN · Traditional	05/19/2026SE
K212189	FibroLuxNHN · Traditional	09/02/2022SE

Questions and answers

When was MR4 Laser cleared by the FDA?

MR4 Laser (K171354) received a 510(k) decision of Substantially Equivalent on January 13, 2018, 249 days after the submission was received.

What is the product code of K171354?

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.