FDA 510(k)

LED 面部護膚罩

K 號：K213056 · 2022-07-07

申請人Shenzhen Osto Technology Company Limited

決定日期2022-07-07

產品代碼OLP

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

LED Facial Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K213056. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LED Facial Mask?

LED Facial Mask is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K213056.

When did LED Facial Mask receive FDA 510(k) clearance?

LED Facial Mask received FDA 510(k) clearance on 2022-07-07, under 510(k) number K213056.

Who is the listed applicant for LED Facial Mask?

The FDA 510(k) record lists Shenzhen Osto Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Facial Mask?

The FDA product code for LED Facial Mask is OLP.

其他以 Shenzhen Osto Technology Company Limited 為申請人之記錄

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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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