510(k) Report

Devices descending from K093499

82 later devices reach Hairmax Lasercomb through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103368Hairmax LasercombLexington International, LLC201181—
+2K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002Hubei Yjt Technology Co.,Ltd20232—
+2K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Capillus, LLC201751—
+2K141596Nutra Stim Hair Laser CombNutra Luxe MD, LLC20154—
+2K142573HairMax LaserComb, HairMax LaserCombLexington International, LLC201473—
+2K121920LaserbrushSunetics International Marketing Group, LLC20131—
+2K111714Hairmax Dual 12Lexington International, LLC20110—
+3K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…Hubei Yjt Technology Co.,Ltd20260—
+3K251684Alma TED+ SystemAlma Lasers, Inc.20260—
+3K242747FAQ™ (302)Foreo, Inc.20240—
+3K242620Breo Laser Hair Growth Comb (Scalp 3L)Shenzhen Breo Technology Co., Ltd.20240—
+3K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo…Xtrallux, LLC20220—
+3K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20200—
+3K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20203—
+3K190467iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.20196—
+3K192012Capillus 112, Capillus 244Capillus20191—
+3K183329Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity201931
+3K181308SuperGrow 272, Ultimate 272Super Grow Lasers20180—
+3K180885HairMax LaserLexington International, LLC20185—
+3K173846DermaScalp Laser CapDermascalp, LLC20181—
+3K173729Revian RedPhotonmd, Inc.201819—
+3K173678Diode Laser CapCosmo Far East Technology Limited201816—
+3K171835Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20185—
+3K172982SuperGrow 272, Ultimate 272Super Grow Lasers20171—
+3K170068Softcure 96Wellray Medical Laser, Inc.20170—
+3K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.201722—
+3K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC20161—
+3K161046Laser Helmet LH40-EVOTheradome, Inc.20161—
+3K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC201659—
+4K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.20250—
+4K252325Hair Growth Laser CapCosmo Far East Technology Limited20250—
+4K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S…Dongguan Boyuan Intelligent Technology Co.,Ltd20251—
+4K242619GroWell BT Hair Growth System (GW10042)Apira Science, Inc.20240—
+4K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd.20244—
+4K240472PBM Hair Therapy CapDongguan Tutamen Metalwork Co., Ltd.20240—
+4K240689Robin's EggTelebrands Corporation20240—
+4K242441Revian Lyte (10011)Revian, Inc.20240—
+4K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20242—
+4K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V.20233—
+4K213789Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd.20221—
+4K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd.20225—
+4K211192Grivamax Family of Lasers, Models 272 and 148Leana Orders, Inc.20210—
+4K211038Biophotas Celluma RESTOREBiophotas, Inc.20219—
+4K202631iHelmet Laser CombSlinph Technologies Co., Ltd.20200—
+4K193008Tricoglam Home UseAdvihair S.R.L.20206—
+4K201854CAPOGEN Laser CapNature, Inc.redible, Inc.20203—
+4K192552Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K193667Shapiro MD model laser 272Conversion Labs, Pr, LLC20200—
+4K192627Laser Hair Growth CapShang FA Biotechnology Co.20191—
+4K182562Hair Boom 69Wontech20184—
+4K182501Hair Laser HeadbandPulsaderm, LLC20180—
+4K181878Kiierr 272 Laser, Kiierr 148 LaserKiierr International, LLC20180—
+4K180460Theradome LH40Theradome, Inc.20180—
+4K162071IllumiFlow Laser CapEglobal, LLC201735—
+4K162994Capillus302, Capillus312, Capillus352Capillus, LLC20161—
+4K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.201620—
+5K262183Hair 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—
+5K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd.20260—
+5K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…Ziree Co., Ltd.20260—
+5K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+5K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+5K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited20250—
+5K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.20240—
+5K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd.20231—
+5K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V.20232—
+5K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.Shenzhen Cosbeauty Technology Co., Ltd.20222—
+5K203826LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.20211—
+5K200464LG Pra. L Derma LD Scalp CareLg Electronics.Inc20207—
+5K191154Hair Boom 69Wontech20193—
+5K190685Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20190—
+5K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20184—
+5K173843illumiflow 148 Laser CapEglobal, LLC20180—
+5K171895Grivamax Hair Growth SystemLeana Orders, Inc.20176—
+6K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+6K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd20230—
+6K222477Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd.20222—
+6K210169Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd.20216—
+6K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd.20192—
+7K231153Neuhat Hair Growth System; ibeauty.com Laser CapNature, Inc.redible, Inc.20231—
+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—