FDA 510(k)

戰神

K 號：K233099 · 2024-05-22

決定日期2024-05-22

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

Gladiator is the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K233099. 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 Gladiator?

Gladiator is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K233099.

When did Gladiator receive FDA 510(k) clearance?

Gladiator received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233099.

Who is the listed applicant for Gladiator?

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

What is the FDA product code for Gladiator?

The FDA product code for Gladiator is GEI.

其他以 Rohrer Aesthetics, LLC 為申請人之記錄

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官方來源

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