FDA 510(k)

維布羅盧克斯

K 號：K212189 · 2022-09-02

決定日期2022-09-02

產品代碼NHN

諮詢委員會PM

決定相當於

器材摘要

FibroLux is the device name listed in this FDA 510(k) record. The listed applicant is Multi Radiance Medical. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K212189. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FibroLux?

FibroLux is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Multi Radiance Medical. The 510(k) number is K212189.

When did FibroLux receive FDA 510(k) clearance?

FibroLux received FDA 510(k) clearance on 2022-09-02, under 510(k) number K212189.

Who is the listed applicant for FibroLux?

The FDA 510(k) record lists Multi Radiance Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FibroLux?

The FDA product code for FibroLux is NHN.

其他以 Multi Radiance Medical 為申請人之記錄

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K171354MR4 激光器

相關器械（代碼：NHN）

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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