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FDA 510(k)

Biophotas Celluma RESTORE

K-Number: K211038 · 2021-06-29

ApplicantBiophotas, Inc.
Decision Date2021-06-29
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Biophotas Celluma RESTORE is the device name listed in this FDA 510(k) record. The listed applicant is Biophotas, Inc.. It received FDA 510(k) clearance on 2021-06-29 under 510(k) number K211038. 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 Biophotas Celluma RESTORE?

Biophotas Celluma RESTORE is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is Biophotas, Inc.. The 510(k) number is K211038.

When did Biophotas Celluma RESTORE receive FDA 510(k) clearance?

Biophotas Celluma RESTORE received FDA 510(k) clearance on 2021-06-29, under 510(k) number K211038.

Who is the listed applicant for Biophotas Celluma RESTORE?

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

What is the FDA product code for Biophotas Celluma RESTORE?

The FDA product code for Biophotas Celluma RESTORE is OAP.

Other records listing Biophotas, Inc. 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.

K232977Biophotas Celluma CONTOURK171323BIOPHOTAS CELLUMA3K152280BioPhotas Celluma3

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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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