FDA 510(k)

Renuvion/J-Plasma Precise Handpiece

K-번호: K191484 · 2019-07-30

신청자Apyx Medical Corporation(Formerly Bovie Medical Corporation)

결정일2019-07-30

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

Renuvion/J-Plasma Precise 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 2019-07-30 under 510(k) number K191484. 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/J-Plasma Precise Handpiece?

Renuvion/J-Plasma Precise Handpiece is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K191484.

When did Renuvion/J-Plasma Precise Handpiece receive FDA 510(k) clearance?

Renuvion/J-Plasma Precise Handpiece received FDA 510(k) clearance on 2019-07-30, under 510(k) number K191484.

Who is the listed applicant for Renuvion/J-Plasma Precise 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/J-Plasma Precise Handpiece?

The FDA product code for Renuvion/J-Plasma Precise Handpiece is GEI.

Apyx Medical Corporation(Formerly Bovie Medical Corporation)를 신청인으로 등재한 기타 기록

K220970Renuvion APR Handpiece K211652Renuvion Dermal Handpiece, Renuvion Dermal System K202880J-Plasma Precise FLEX Handpiece

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