FDA 510(k)

雷射頭盔 LH40-EVO

K 號：K161046 · 2016-05-12

決定日期2016-05-12

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Laser Helmet LH40-EVO is the device name listed in this FDA 510(k) record. The listed applicant is Theradome, Inc.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K161046. 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 Laser Helmet LH40-EVO?

Laser Helmet LH40-EVO is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Theradome, Inc.. The 510(k) number is K161046.

When did Laser Helmet LH40-EVO receive FDA 510(k) clearance?

Laser Helmet LH40-EVO received FDA 510(k) clearance on 2016-05-12, under 510(k) number K161046.

Who is the listed applicant for Laser Helmet LH40-EVO?

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

What is the FDA product code for Laser Helmet LH40-EVO?

The FDA product code for Laser Helmet LH40-EVO is OAP.

其他以 Theradome, Inc. 為申請人之記錄

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K180460Theradome LH40 K171775Theradome LH80 PRO

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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