510(k) Report

Devices descending from K122950

46 later devices reach Laser Helmet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20203—
+1K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20184—
+1K173729Revian RedPhotonmd, Inc.201819—
+1K171775Theradome LH80 PROTheradome, Inc.20181—
+1K161046Laser Helmet LH40-EVOTheradome, Inc.20161—
+1K151516Capillus82Capillus, LLC201524—
+1K142824LX-100 Hair Growth Stimulation SystemHairlabs International, Inc.20150—
+1K132646Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC20133—
+2K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.20250—
+2K242619GroWell BT Hair Growth System (GW10042)Apira Science, Inc.20240—
+2K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd.20244—
+2K240472PBM Hair Therapy CapDongguan Tutamen Metalwork Co., Ltd.20240—
+2K240689Robin's EggTelebrands Corporation20240—
+2K242441Revian Lyte (10011)Revian, Inc.20240—
+2K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20242—
+2K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V.20233—
+2K211038Biophotas Celluma RESTOREBiophotas, Inc.20219—
+2K193008Tricoglam Home UseAdvihair S.R.L.20206—
+2K190685Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20190—
+2K180460Theradome LH40Theradome, Inc.20180—
+2K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.201620—
+2K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC20161—
+3K262183Hair 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—
+3K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd.20260—
+3K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+3K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+3K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited20250—
+3K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.20240—
+3K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd.20231—
+3K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V.20232—
+3K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd.20225—
+3K203826LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.20211—
+3K182501Hair Laser HeadbandPulsaderm, LLC20180—
+3K180885HairMax LaserLexington International, LLC20185—
+3K173846DermaScalp Laser CapDermascalp, LLC20181—
+3K173843illumiflow 148 Laser CapEglobal, LLC20180—
+3K162994Capillus302, Capillus312, Capillus352Capillus, LLC20161—
+4K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+4K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+4K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd20230—
+4K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20200—
+4K182562Hair Boom 69Wontech20184—
+5K191154Hair Boom 69Wontech20193—
+6K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd.20192—
+7K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd.20231—
+8K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd.20240—