FDA 510(k)

二極雷射帽

K 號：K173678 · 2018-02-28

決定日期2018-02-28

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Diode Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Cosmo Far East Technology Limited. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173678. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diode Laser Cap?

Diode Laser Cap is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Cosmo Far East Technology Limited. The 510(k) number is K173678.

When did Diode Laser Cap receive FDA 510(k) clearance?

Diode Laser Cap received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173678.

Who is the listed applicant for Diode Laser Cap?

The FDA 510(k) record lists Cosmo Far East Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Cap?

The FDA product code for Diode Laser Cap is OAP.

其他以 Cosmo Far East Technology Limited 為申請人之記錄

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K252325頭髮生長雷射帽

相關器械（代碼：OAP）

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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