FDA 510(k)

MR4 Laser

K-Number: K171354 · 2018-01-13

Decision Date2018-01-13

Product CodeNHN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MR4 Laser is the device name listed in this FDA 510(k) record. The listed applicant is Multi Radiance Medical. It received FDA 510(k) clearance on 2018-01-13 under 510(k) number K171354. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR4 Laser?

MR4 Laser is a medical device that received FDA 510(k) clearance on 2018-01-13. The listed applicant is Multi Radiance Medical. The 510(k) number is K171354.

When did MR4 Laser receive FDA 510(k) clearance?

MR4 Laser received FDA 510(k) clearance on 2018-01-13, under 510(k) number K171354.

Who is the listed applicant for MR4 Laser?

The FDA 510(k) record lists Multi Radiance Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR4 Laser?

The FDA product code for MR4 Laser is NHN.

Other records listing Multi Radiance Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254024MR5 Activ Pro K212189FibroLux

Related Devices (Code: NHN)

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.