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FDA 510(k)

REVIAN RED

K-Number: K173729 · 2018-02-28

ApplicantPhotonmd, Inc.
Decision Date2018-02-28
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REVIAN RED is the device name listed in this FDA 510(k) record. The listed applicant is Photonmd, Inc.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173729. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVIAN RED?

REVIAN RED is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Photonmd, Inc.. The 510(k) number is K173729.

When did REVIAN RED receive FDA 510(k) clearance?

REVIAN RED received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173729.

Who is the listed applicant for REVIAN RED?

The FDA 510(k) record lists Photonmd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVIAN RED?

The FDA product code for REVIAN RED is OAP.

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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.

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