FDA 510(k)

LED眼眸修護器，型號：EY-36A，EY-36B

K 號：K221444 · 2022-12-08

決定日期2022-12-08

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

LED Eye Perfector, model: EY-36A, EY-36B is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K221444. 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 LED Eye Perfector, model: EY-36A, EY-36B?

LED Eye Perfector, model: EY-36A, EY-36B is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K221444.

When did LED Eye Perfector, model: EY-36A, EY-36B receive FDA 510(k) clearance?

LED Eye Perfector, model: EY-36A, EY-36B received FDA 510(k) clearance on 2022-12-08, under 510(k) number K221444.

Who is the listed applicant for LED Eye Perfector, model: EY-36A, EY-36B?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Eye Perfector, model: EY-36A, EY-36B?

The FDA product code for LED Eye Perfector, model: EY-36A, EY-36B is OHS.

其他以 Light Tree Ventures Europe B.V. 為申請人之記錄

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相關器械（代碼：OHS）

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