FDA 510(k)

Renuvion/J-Plasma 精确手持器

K号: K191484 · 2019-07-30

申请人Apyx Medical Corporation(Formerly Bovie Medical Corporation)

决定日期2019-07-30

产品代码GEI

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Apyx Medical Corporation(Formerly Bovie Medical Corporation)为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220970Renuvion APR 手持器 K211652Renuvion Dermal 手持器，Renuvion Dermal 系统 K202880J-Plasma Precise FLEX手柄

相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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