FDA 510(k)

生物光療 Celluma RESTORE

K 號：K211038 · 2021-06-29

決定日期2021-06-29

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

其他以 Biophotas, Inc. 為申請人之記錄

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K232977生物光療 Celluma CONTOUR K171323BIOPHOTAS細胞美3 K152280生物光療 Celluma3

相關器械（代碼：OAP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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