510(k) Report

Devices descending from K012580

77 later devices reach Erchonia PL2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..20251—
+1K190572Erchonia FX-635Erchonia Corporation20192—
+1K050668GRT Lite, Model 8-aGrt Solutions, Inc.20069—
+1K041530Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc.200412—
+1K032816Quantum Light Therapy SystemStargate International, Inc.200473—
+2K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda20250—
+2K212595Erchonia FX-405Erchonia Corporation20211—
+2K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC201058—
+2K083822Laser TouchoneLaser Health Technologies, LLC20091—
+2K081141Combocare 2000Xanacare Technologies, LLC20086—
+2K051631Excalibur IV Light Therapy System, Model SGEX4-001Stargate International, Inc.20050—
+2K043353Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc.20051—
+3K231409Erchonia FX-405Erchonia Corporation20230—
+3K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+3K151516Capillus82Capillus, LLC201524—
+3K142824LX-100 Hair Growth Stimulation SystemHairlabs International, Inc.20150—
+3K142025Neurolumen PN-1000Neurolumen, LLC20150—
+3K132646Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC20133—
+3K122950Laser HelmetTheradome, Inc.201346—
+3K113097Laser HelmetTheradome, Inc.201257—
+3K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+3K083202Combocare 2000Xanacare Technologies, LLC20082—
+3K072551LD-I 75 and LD-I 200Meditech International, Inc.20080—
+4K193008Tricoglam Home UseAdvihair S.R.L.20206—
+4K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20203—
+4K190685Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20190—
+4K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20184—
+4K173729Revian RedPhotonmd, Inc.201819—
+4K171775Theradome LH80 PROTheradome, Inc.20181—
+4K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.201620—
+4K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC20161—
+4K161046Laser Helmet LH40-EVOTheradome, Inc.20161—
+4K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc.201546—
+4K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+5K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.20250—
+5K242619GroWell BT Hair Growth System (GW10042)Apira Science, Inc.20240—
+5K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd.20244—
+5K240472PBM Hair Therapy CapDongguan Tutamen Metalwork Co., Ltd.20240—
+5K240689Robin's EggTelebrands Corporation20240—
+5K242441Revian Lyte (10011)Revian, Inc.20240—
+5K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20242—
+5K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V.20233—
+5K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd.20225—
+5K211038Biophotas Celluma RESTOREBiophotas, Inc.20219—
+5K203826LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.20211—
+5K182501Hair Laser HeadbandPulsaderm, LLC20180—
+5K180885HairMax LaserLexington International, LLC20185—
+5K180460Theradome LH40Theradome, Inc.20180—
+5K173846DermaScalp Laser CapDermascalp, LLC20181—
+5K173843illumiflow 148 Laser CapEglobal, LLC20180—
+5K162994Capillus302, Capillus312, Capillus352Capillus, LLC20161—
+5K152587DermaScalp Laser CapDermascalp, LLC20160—
+5K153618Capillus202Capillus, LLC201644—
+6K262183Hair 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—
+6K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd.20260—
+6K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited20250—
+6K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.20240—
+6K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd20230—
+6K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd.20231—
+6K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V.20232—
+6K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20200—
+6K192552Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K190467iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.20196—
+6K182562Hair Boom 69Wontech20184—
+6K171835Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.201722—
+7K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+7K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+7K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S…Dongguan Boyuan Intelligent Technology Co.,Ltd20251—
+7K192627Laser Hair Growth CapShang FA Biotechnology Co.20191—
+7K191154Hair Boom 69Wontech20193—
+8K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…Ziree Co., Ltd.20260—
+8K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd.20192—
+9K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd.20231—
+10K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd.20240—