510(k) Report

Devices descending from K122248

80 later devices reach Igrow II Hair Growth System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Capillus, LLC201751—
+1K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC201659—
+1K140931Igrow II Hair Growth SystemApira Science, Inc.201476—
+1K132646Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC20133—
+2K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…Hubei Yjt Technology Co.,Ltd20260—
+2K242619GroWell BT Hair Growth System (GW10042)Apira Science, Inc.20240—
+2K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo…Xtrallux, LLC20220—
+2K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20200—
+2K192552Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20202—
+2K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20203—
+2K190467iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.20196—
+2K192012Capillus 112, Capillus 244Capillus20191—
+2K190685Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20190—
+2K181308SuperGrow 272, Ultimate 272Super Grow Lasers20180—
+2K180885HairMax LaserLexington International, LLC20185—
+2K180617Hair UpY & J Bio Co., Ltd.20181—
+2K173846DermaScalp Laser CapDermascalp, LLC20181—
+2K173678Diode Laser CapCosmo Far East Technology Limited201816—
+2K171835Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20185—
+2K172982SuperGrow 272, Ultimate 272Super Grow Lasers20171—
+2K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.201722—
+2K162071IllumiFlow Laser CapEglobal, LLC201735—
+2K162994Capillus302, Capillus312, Capillus352Capillus, LLC20161—
+2K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.201620—
+2K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC20161—
+2K161046Laser Helmet LH40-EVOTheradome, Inc.20161—
+2K151662iRestoreFreedom Laser Therapy, Inc.201615—
+2K152019HairMDTrophy Skin, Inc.201522—
+3K252325Hair Growth Laser CapCosmo Far East Technology Limited20250—
+3K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S…Dongguan Boyuan Intelligent Technology Co.,Ltd20251—
+3K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20242—
+3K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd.20231—
+3K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd.20225—
+3K211192Grivamax Family of Lasers, Models 272 and 148Leana Orders, Inc.20210—
+3K211038Biophotas Celluma RESTOREBiophotas, Inc.20219—
+3K210169Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd.20216—
+3K203826LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.20211—
+3K202983easy HairfullY & J Bio Co., Ltd.20200—
+3K193008Tricoglam Home UseAdvihair S.R.L.20206—
+3K201854CAPOGEN Laser CapNature, Inc.redible, Inc.20203—
+3K200464LG Pra. L Derma LD Scalp CareLg Electronics.Inc20207—
+3K193667Shapiro MD model laser 272Conversion Labs, Pr, LLC20200—
+3K192627Laser Hair Growth CapShang FA Biotechnology Co.20191—
+3K183417iRestore Professional 282Freedom Laser Therapy, Inc.20198—
+3K182562Hair Boom 69Wontech20184—
+3K182501Hair Laser HeadbandPulsaderm, LLC20180—
+3K181878Kiierr 272 Laser, Kiierr 148 LaserKiierr International, LLC20180—
+3K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20184—
+3K180460Theradome LH40Theradome, Inc.20180—
+3K173729Revian RedPhotonmd, Inc.201819—
+3K173843illumiflow 148 Laser CapEglobal, LLC20180—
+3K171895Grivamax Hair Growth SystemLeana Orders, Inc.20176—
+4K262183Hair 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—
+4K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd.20260—
+4K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…Ziree Co., Ltd.20260—
+4K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+4K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.20250—
+4K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+4K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited20250—
+4K242747FAQ™ (302)Foreo, Inc.20240—
+4K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd.20244—
+4K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.20240—
+4K240472PBM Hair Therapy CapDongguan Tutamen Metalwork Co., Ltd.20240—
+4K240689Robin's EggTelebrands Corporation20240—
+4K242441Revian Lyte (10011)Revian, Inc.20240—
+4K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd20230—
+4K231153Neuhat Hair Growth System; ibeauty.com Laser CapNature, Inc.redible, Inc.20231—
+4K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V.20232—
+4K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V.20233—
+4K222477Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd.20222—
+4K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.Shenzhen Cosbeauty Technology Co., Ltd.20222—
+4K213094ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc.20215—
+4K191154Hair Boom 69Wontech20193—
+5K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+5K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+5K222081ID-510 iRestore EliteFreedom Laser Therapy, Inc.20224—
+5K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd.20192—
+6K252414Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd.20231—
+7K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd.20240—