FDA 510(k)

Alma Opus 系統，Colibri 濾射器及針頭

K 號：K201520 · 2021-10-27

決定日期2021-10-27

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

The Alma Opus System, Colibri Applicator and Tips is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2021-10-27 under 510(k) number K201520. 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 The Alma Opus System, Colibri Applicator and Tips?

The Alma Opus System, Colibri Applicator and Tips is a medical device that received FDA 510(k) clearance on 2021-10-27. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K201520.

When did The Alma Opus System, Colibri Applicator and Tips receive FDA 510(k) clearance?

The Alma Opus System, Colibri Applicator and Tips received FDA 510(k) clearance on 2021-10-27, under 510(k) number K201520.

Who is the listed applicant for The Alma Opus System, Colibri Applicator and Tips?

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

What is the FDA product code for The Alma Opus System, Colibri Applicator and Tips?

The FDA product code for The Alma Opus System, Colibri Applicator and Tips is GEI.

其他以 Alma Lasers, Inc. 為申請人之記錄

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