Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Multi Radiance Medical. It received FDA 510(k) clearance on 2018-01-13 under approval 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. It is manufactured by Multi Radiance Medical. The 510(k) number is K171354.

When was MR4 Laser approved by the FDA?

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

What company makes MR4 Laser?

MR4 Laser is manufactured by Multi Radiance Medical.

What is the FDA product code for MR4 Laser?

The FDA product code for MR4 Laser is NHN.

Other Devices by Multi Radiance Medical

Related Devices (Code: NHN)

Official Source

View on FDA Database →

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