FDA 510(k)

多切單人版

K 號：K213597 · 2023-01-18

決定日期2023-01-18

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

MultiCut Solo is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K213597. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MultiCut Solo?

MultiCut Solo is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K213597.

When did MultiCut Solo receive FDA 510(k) clearance?

MultiCut Solo received FDA 510(k) clearance on 2023-01-18, under 510(k) number K213597.

Who is the listed applicant for MultiCut Solo?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiCut Solo?

The FDA product code for MultiCut Solo is GCJ.

其他以 Asclepion Laser Technologies GmbH 為申請人之記錄

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相關器械（代碼：GCJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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