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FDA 510(k)

Biophotas Celluma CONTOUR

K-Number: K232977 · 2023-11-21

ApplicantBiophotas, Inc.
Decision Date2023-11-21
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biophotas Celluma CONTOUR is the device name listed in this FDA 510(k) record. The listed applicant is Biophotas, Inc.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232977. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biophotas Celluma CONTOUR?

Biophotas Celluma CONTOUR is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Biophotas, Inc.. The 510(k) number is K232977.

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

Biophotas Celluma CONTOUR received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232977.

Who is the listed applicant for Biophotas Celluma CONTOUR?

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 CONTOUR?

The FDA product code for Biophotas Celluma CONTOUR is OLI.

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.

K211038Biophotas Celluma RESTOREK171323BIOPHOTAS CELLUMA3K152280BioPhotas Celluma3

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Official Source

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