510(k) Report

Devices descending from K222081

4 later devices reach ID-510 iRestore Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.20260—
+1K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+1K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…Hubei Yjt Technology Co.,Ltd20260—
+1K252414Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—