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
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB20083—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K072906SILK'NHome Skinovations, Ltd.2008169—
+5K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+5K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+5K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+5K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+5K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+5K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+5K043032Dealight IplEuropro, Inc.20050—
+5K051255Lumiphase-ROpusmed, Inc.2005143—
+5K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+5K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+5K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+5K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+5K030186Polris LVSyneron Medical, Ltd.2003680—
+6K261975Braun Aura 7 (6041)CyDen Limited20260—
+6K261977Braun Aura 9 (6042)Cyden Limited20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250384IPL400El Global Trade, Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+6K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+6K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+6K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K222556BTL-785XBTL Industries, Inc.20235—