510(k) Report

Devices descending from K950019

1,568 later devices reach Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230090Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd.20230—
+6K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+6K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+6K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+6K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K203054FlexSysGme German Medical Engineering GmbH20210—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K193201BTL-785FBtl20208—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K191086ExciplexClarteis20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191693BC-5Reveallux, Corp20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K140386Lumina 24Rogers Sciences, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+6K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—