FDA 510(k)

Grivamax 髮絲生長系統

K 號：K171895 · 2017-08-22

決定日期2017-08-22

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Grivamax Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Leana Orders, Inc.. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K171895. 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 Grivamax Hair Growth System?

Grivamax Hair Growth System is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Leana Orders, Inc.. The 510(k) number is K171895.

When did Grivamax Hair Growth System receive FDA 510(k) clearance?

Grivamax Hair Growth System received FDA 510(k) clearance on 2017-08-22, under 510(k) number K171895.

Who is the listed applicant for Grivamax Hair Growth System?

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

What is the FDA product code for Grivamax Hair Growth System?

The FDA product code for Grivamax Hair Growth System is OAP.

其他以 Leana Orders, 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。

K211192Grivamax雷射系列，型號272及148

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

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