FDA 510(k)

BEAU RX SCAR CARE GEL

K-Number: K083718 · 2009-01-26

Decision Date2009-01-26

Product CodeMDA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BEAU RX SCAR CARE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Beau RX Solutions, LLC. It received FDA 510(k) clearance on 2009-01-26 under 510(k) number K083718. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAU RX SCAR CARE GEL?

BEAU RX SCAR CARE GEL is a medical device that received FDA 510(k) clearance on 2009-01-26. The listed applicant is Beau RX Solutions, LLC. The 510(k) number is K083718.

When did BEAU RX SCAR CARE GEL receive FDA 510(k) clearance?

BEAU RX SCAR CARE GEL received FDA 510(k) clearance on 2009-01-26, under 510(k) number K083718.

Who is the listed applicant for BEAU RX SCAR CARE GEL?

The FDA 510(k) record lists Beau RX Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEAU RX SCAR CARE GEL?

The FDA product code for BEAU RX SCAR CARE GEL is MDA.

Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, Inc.K024057CURAD SCAR THERAPYBeiersdorf, Inc.

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.