FDA 510(k)

Renuvion Dermal Handpiece, Renuvion Dermal System

K-번호: K211652 · 2022-05-25

신청자Apyx Medical Corporation (Formerly Bovie Medical Corporation

결정일2022-05-25

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Apyx Medical Corporation (Formerly Bovie Medical Corporation를 신청인으로 등재한 기타 기록

K220970Renuvion APR Handpiece K202880J-Plasma Precise FLEX Handpiece K191484Renuvion/J-Plasma Precise Handpiece

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