FDA 510(k)

J-プラズマプレシスFLEXハンドピース

K番号: K202880 · 2021-01-04

申請者Apyx Medical Corporation (Formerly Bovie Medical Corporation

決定日2021-01-04

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

J-Plasma Precise FLEX 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 2021-01-04 under 510(k) number K202880. 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 J-Plasma Precise FLEX Handpiece?

J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2021-01-04. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K202880.

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

J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2021-01-04, under 510(k) number K202880.

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

The FDA product code for J-Plasma Precise FLEX 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

K220970レヌビオンAPRハンドピース 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 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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