FDA 510(k)

レヌビオンAPRハンドピース

K番号: K220970 · 2022-07-15

申請者Apyx Medical Corporation(Formerly Bovie Medical Corporation)

決定日2022-07-15

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてApyx Medical Corporation(Formerly Bovie Medical Corporation)を記載するその他の記録

K211652レヌビオン・デマル・ハンドピース、レヌビオン・デマル・システム K202880J-プラズマプレシスFLEXハンドピース K191484レヌビオン/J-プラズマプレシスハンドピース

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