FDA 510(k)

B.Light Clear Evo 及 B.Light Restore Evo

K 號：K223919 · 2023-09-23

決定日期2023-09-23

產品代碼OHS

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

B.Light Clear Evo and B.Light Restore Evo is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2023-09-23 under 510(k) number K223919. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the B.Light Clear Evo and B.Light Restore Evo?

B.Light Clear Evo and B.Light Restore Evo is a medical device that received FDA 510(k) clearance on 2023-09-23. The listed applicant is Bemer Int AG. The 510(k) number is K223919.

When did B.Light Clear Evo and B.Light Restore Evo receive FDA 510(k) clearance?

B.Light Clear Evo and B.Light Restore Evo received FDA 510(k) clearance on 2023-09-23, under 510(k) number K223919.

Who is the listed applicant for B.Light Clear Evo and B.Light Restore Evo?

The FDA 510(k) record lists Bemer Int AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B.Light Clear Evo and B.Light Restore Evo?

The FDA product code for B.Light Clear Evo and B.Light Restore Evo is OHS.

其他以 Bemer Int AG 為申請人之記錄

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