FDA 510(k)

Biophotas Celluma CONTOUR

K号: K232977 · 2023-11-21

决定日期2023-11-21

产品代码OLI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Biophotas, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K211038Biophotas Celluma RESTORE K171323BIOPHOTAS CELLUMA3 K152280BioPhotas Celluma3

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