FDA 510(k)

LED光療設備

K 號：K180900 · 2018-07-10

決定日期2018-07-10

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 Light Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Uvbiotek, LLC. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180900. 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 Light Therapy Device?

LED Light Therapy Device is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Uvbiotek, LLC. The 510(k) number is K180900.

When did LED Light Therapy Device receive FDA 510(k) clearance?

LED Light Therapy Device received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180900.

Who is the listed applicant for LED Light Therapy Device?

The FDA 510(k) record lists Uvbiotek, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Device?

The FDA product code for LED Light Therapy Device is OLP.

其他以 Uvbiotek, LLC 為申請人之記錄

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K170187光動治療設備

相關器械（代碼：OLP）

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官方來源

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