FDA 510(k)

Renuvion 皮膚手柄，Renuvion 皮膚系統

K 號：K211652 · 2022-05-25

申請人Apyx Medical Corporation (Formerly Bovie Medical Corporation

決定日期2022-05-25

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 Dermal Handpiece, Renuvion Dermal System 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 2022-05-25 under 510(k) number K211652. 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 Dermal Handpiece, Renuvion Dermal System?

Renuvion Dermal Handpiece, Renuvion Dermal System is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K211652.

When did Renuvion Dermal Handpiece, Renuvion Dermal System receive FDA 510(k) clearance?

Renuvion Dermal Handpiece, Renuvion Dermal System received FDA 510(k) clearance on 2022-05-25, under 510(k) number K211652.

Who is the listed applicant for Renuvion Dermal Handpiece, Renuvion Dermal System?

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 Dermal Handpiece, Renuvion Dermal System?

The FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System is GEI.

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

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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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