FDA 510(k)

YandR 系統，VoluDerm 手柄，VoluDerm 筆尖

K 號：K220124 · 2022-02-17

決定日期2022-02-17

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

YandR System, VoluDerm Handpiece, VoluDerm Tips is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K220124. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the YandR System, VoluDerm Handpiece, VoluDerm Tips?

YandR System, VoluDerm Handpiece, VoluDerm Tips is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Pollogen, Ltd.. The 510(k) number is K220124.

When did YandR System, VoluDerm Handpiece, VoluDerm Tips receive FDA 510(k) clearance?

YandR System, VoluDerm Handpiece, VoluDerm Tips received FDA 510(k) clearance on 2022-02-17, under 510(k) number K220124.

Who is the listed applicant for YandR System, VoluDerm Handpiece, VoluDerm Tips?

The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YandR System, VoluDerm Handpiece, VoluDerm Tips?

The FDA product code for YandR System, VoluDerm Handpiece, VoluDerm Tips is GEI.

其他以 Pollogen, Ltd. 為申請人之記錄

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