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FDA 510(k)

BioPhotas Celluma3

K-Number: K152280 · 2016-03-02

ApplicantBiophotas, Inc.
Decision Date2016-03-02
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BioPhotas Celluma3 is the device name listed in this FDA 510(k) record. The listed applicant is Biophotas, Inc.. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K152280. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioPhotas Celluma3?

BioPhotas Celluma3 is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Biophotas, Inc.. The 510(k) number is K152280.

When did BioPhotas Celluma3 receive FDA 510(k) clearance?

BioPhotas Celluma3 received FDA 510(k) clearance on 2016-03-02, under 510(k) number K152280.

Who is the listed applicant for BioPhotas Celluma3?

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 Celluma3?

The FDA product code for BioPhotas Celluma3 is ILY.

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 CONTOURK211038Biophotas Celluma RESTOREK171323BIOPHOTAS 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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