FDA 510(k)

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

K番号: K211652 · 2022-05-25

申請者Apyx Medical Corporation (Formerly Bovie Medical Corporation

決定日2022-05-25

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 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.

よくある質問

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.

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

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公式ソース

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