FDA 510(k)

雷射帽系列 300、224、120 及 80

K 號：K203826 · 2021-03-29

決定日期2021-03-29

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

LaserCap Family of Lasers 300, 224, 120 & 80 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 2021-03-29 under 510(k) number K203826. 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 LaserCap Family of Lasers 300, 224, 120 & 80?

LaserCap Family of Lasers 300, 224, 120 & 80 is a medical device that received FDA 510(k) clearance on 2021-03-29. The listed applicant is Transdermal Cap, Inc.. The 510(k) number is K203826.

When did LaserCap Family of Lasers 300, 224, 120 & 80 receive FDA 510(k) clearance?

LaserCap Family of Lasers 300, 224, 120 & 80 received FDA 510(k) clearance on 2021-03-29, under 510(k) number K203826.

Who is the listed applicant for LaserCap Family of Lasers 300, 224, 120 & 80?

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 LaserCap Family of Lasers 300, 224, 120 & 80?

The FDA product code for LaserCap Family of Lasers 300, 224, 120 & 80 is OAP.

其他以 Transdermal Cap, Inc. 為申請人之記錄

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。

K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80

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。

K262183生髮頭盔（TK-176、TK-600、TK-500、TK-282、TK-500A、TK-282A、TK-126、TK-60）Shenzhen Nuon Medical Equipment Co., Ltd.K262254髮絲生長梳（X-GC01）Guangdong Ashmore Health Technology Co., Ltd.K261675CHZL紅光治療頭盔（型號：CHZL-120BK-L52D、CHZL-120BK-L53D、CHZL-120BK-L54D）Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253雷射頭髮生長設備（HR-H1、HR-H2、HR-H3、HR-H4、HR-H5、HR-H6、HR-H7、HR-H8、HR-H9、HR-H10、HR-I1、HR-I2、HR-I3、HR-I4、HR-I5）Ziree Co., Ltd.K253231雷射頭髮生長系統（雷射帽128，雷射頭盔272，雷射頭盔352，雷射頭盔552，雷射頭盔500）Hubei Yjt Technology Co.,Ltd K260899雷射頭髮生長設備（F21151、F21152、F21153、F21154、F21155、F21156、F21157、F21158、F21159）Zdeer Technology (Henan) Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。