FDA 510(k)

Renuvion APR 手柄

K 號：K220970 · 2022-07-15

申請人Apyx Medical Corporation(Formerly Bovie Medical Corporation)

決定日期2022-07-15

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Renuvion APR Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation(Formerly Bovie Medical Corporation). It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K220970. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Renuvion APR Handpiece?

Renuvion APR Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K220970.

When did Renuvion APR Handpiece receive FDA 510(k) clearance?

Renuvion APR Handpiece received FDA 510(k) clearance on 2022-07-15, under 510(k) number K220970.

Who is the listed applicant for Renuvion APR Handpiece?

The FDA 510(k) record lists Apyx Medical Corporation(Formerly Bovie Medical Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renuvion APR Handpiece?

The FDA product code for Renuvion APR Handpiece is GEI.

其他以 Apyx Medical Corporation(Formerly Bovie Medical Corporation) 為申請人之記錄

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。

K211652Renuvion 皮膚手柄，Renuvion 皮膚系統 K202880J-Plasma精準FLEX手持式器具 K191484Renuvion/J-Plasma精準手持器

相關器械（代碼：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片，按鈕開關（0703-046-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，按鈕開關，大量非無菌（0703-046-102）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片， rocking 開關（0703-047-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，rocking 開關，大量非無菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 馬里蘭頰部血管黏合器/分離器，納米塗層Covidien, LLC K254185波坦茲·普瑞美Jeisys Medical Incorporated K262364艾利安恩尼格瑪雷射設備Ellian Corp K253859紅色專業版（Scarlet Pro）VIOL Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。