510(k) Report

Devices descending from K020017

187 later devices reach Medx 1000 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090008Tanda Restore, Model PtscsPharos Life Corporation20096—
+1K050022Medx HomeMedx Electronics, Inc.20050—
+1K030275MB System, Bioenergy Light TherapyAmest Corp.20040—
+1K033183Reclear Phototherapy System, Model FGCM0012Curelight, Ltd.20040—
+1K032816Quantum Light Therapy SystemStargate International, Inc.200473—
+1K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315—
+1K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Dynatronics Corp.200337—
+1K032231MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable LaserMedx Electronics, Inc.200374—
+2K162763Vevazz LED Heat LampVevazz, LLC20170—
+2K120835Dynatron Thermostim Probe-DoneDynatronics Corporation20121—
+2K120582HeatluxHome Skinovations, Ltd.20123—
+2K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC20121—
+2K113250Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light ProbeDynatronics Corp.20120—
+2K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC201058—
+2K083822Laser TouchoneLaser Health Technologies, LLC20091—
+2K082707Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc.200859—
+2K080084Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC20081—
+2K062256HF54 Combination Ultrasound Interferential and Premodulated Stimulation SystemHill Laboratories Co.20072—
+2K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+2K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+2K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+2K051680Dynatron DX2 Traction UnitDynatronics Corp.20050—
+2K051631Excalibur IV Light Therapy System, Model SGEX4-001Stargate International, Inc.20050—
+2K051261Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light ProbeDynatronics Corp.20051—
+2K043586Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp.200513—
+2K041530Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc.200412—
+2K040729Solaris D890 Therapy ProbeDynatronics Corp.200428—
+2K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410—
+3K213524CytonPro-5000Cytonsys, Inc.20220—
+3K193656SkyPulseFotona D.O.O.202011—
+3K150716Varaya SportVaraya Photoceuticals, LLC20150—
+3K151516Capillus82Capillus, LLC201524—
+3K150466ZX2 Laser SystemLzr7, Inc.20150—
+3K142824LX-100 Hair Growth Stimulation SystemHairlabs International, Inc.20150—
+3K150175HeatLux Pro IHome Skinovations, Ltd.20151—
+3K132057Dynatron Peltier Thermostim ProbeDynatronics Corp.20140—
+3K132646Sunetics Clinical Bio-Stimulation LaserSunetics International Marketing Group, LLC20133—
+3K122950Laser HelmetTheradome, Inc.201346—
+3K113017Sys*Stim 240Mettler Electronics Corp.20129—
+3K113097Laser HelmetTheradome, Inc.201257—
+3K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+3K083595EzlaseBiolase Technology, Inc.200958—
+3K081141Combocare 2000Xanacare Technologies, LLC20086—
+3K072256HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with…Hill Laboratories Co.20081—
+3K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068—
+3K050668GRT Lite, Model 8-aGrt Solutions, Inc.20069—
+3K043353Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc.20051—
+3K050070K-Laser, Models 3,4,4D,6DEltech S.R.L200512—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..20251—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K223802accufitMettler Electronics Corporation20235—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC20231—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+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—
+4K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+4K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.201620—
+4K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC20161—
+4K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+4K161046Laser Helmet LH40-EVOTheradome, Inc.20161—
+4K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc.201546—
+4K142025Neurolumen PN-1000Neurolumen, LLC20150—
+4K132529Gallieon-1 Medical LaserFuture Device and Technology, Inc.20140—
+4K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K090250Electro-Light TherapyHill Laboratories Co.20100—
+4K091497K-Laser K-1200, Model 12 WEltech S.R.L20097—
+4K083202Combocare 2000Xanacare Technologies, LLC20082—
+4K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc.20081—
+4K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+4K072551LD-I 75 and LD-I 200Meditech International, Inc.20080—
+4K070400LC Therapy, Model LCT-1000Litecure, LLC20078—
+4K061656Laser-D68Laser Pain Clinics LP20065—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati20260—
+5K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.20250—
+5K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.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—
+5K233926accufitMettler Electronics Corporation20244—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V.20233—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd.20225—
+5K211038Biophotas Celluma RESTOREBiophotas, Inc.20219—