FDA 510(k)

LaserCap300, LaserCap224, LaserCap120, LaserCap80

K 號：K161875 · 2016-09-30

決定日期2016-09-30

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

LaserCap300, LaserCap224, LaserCap120, LaserCap80 is the device name listed in this FDA 510(k) record. The listed applicant is Transdermal Cap, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161875. 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 LaserCap300, LaserCap224, LaserCap120, LaserCap80?

LaserCap300, LaserCap224, LaserCap120, LaserCap80 is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Transdermal Cap, Inc.. The 510(k) number is K161875.

When did LaserCap300, LaserCap224, LaserCap120, LaserCap80 receive FDA 510(k) clearance?

LaserCap300, LaserCap224, LaserCap120, LaserCap80 received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161875.

Who is the listed applicant for LaserCap300, LaserCap224, LaserCap120, LaserCap80?

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

What is the FDA product code for LaserCap300, LaserCap224, LaserCap120, LaserCap80?

The FDA product code for LaserCap300, LaserCap224, LaserCap120, LaserCap80 is OAP.

其他以 Transdermal Cap, Inc. 為申請人之記錄

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K203826雷射帽系列 300、224、120 及 80

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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