FDA 510(k)

Biophotas Celluma RESTORE

K-Number: K211038 · 2021-06-29

Decision Date2021-06-29

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Biophotas Celluma RESTORE is a medical device manufactured by Biophotas, Inc.. It received FDA 510(k) clearance on 2021-06-29 under approval 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. It is manufactured by Biophotas, Inc.. The 510(k) number is K211038.

When was Biophotas Celluma RESTORE approved by the FDA?

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

What company makes Biophotas Celluma RESTORE?

Biophotas Celluma RESTORE is manufactured by Biophotas, Inc..

What is the FDA product code for Biophotas Celluma RESTORE?

The FDA product code for Biophotas Celluma RESTORE is OAP.

Other Devices by Biophotas, Inc.

K152280BioPhotas Celluma3 K171323BIOPHOTAS CELLUMA3 K232977Biophotas Celluma CONTOUR

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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.