FDA 510(k)

Q-Renew LLLT 髮絲生長頭盔 (Q-HLMT-V1)

K 號：K252414 · 2025-10-30

申請人Shenzhen Kaiyan Medical Equipment Co., Ltd.

決定日期2025-10-30

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252414. 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 Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252414.

When did Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) receive FDA 510(k) clearance?

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252414.

Who is the listed applicant for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

FDA 510(k) 記錄將深圳凱亞醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

The FDA product code for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) is OAP.

其他以 Shenzhen Kaiyan Medical Equipment Co., Ltd. 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。

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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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