510(k) Report

Devices descending from K011092

1,127 later devices reach Candela SPTL-1E Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+4K122493GenesisplusCutera, Inc.201318—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121435Silkn BlueHome Skinovations, Ltd.2013125—
+4K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+4K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K110301Silk'n FXHome Skinovations, Ltd.201166—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K103415Tanda MaxPharos Life Corporation20110—
+4K100628PlasmaluxlsDaavlin Distributing Co.20100—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K091467Baby QuasarSilver Bay, LLC20100—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K093168Mediflash and EsteflashDermeo20100—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090744CLAROClrs Technology Corporation20101—
+4K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+4K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+4K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+4K090724OR-LightYperion Technology20090—
+4K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083730IsolazAesthera Corporation20093—
+4K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K063828Diomed Delta 25Diomed, Ltd.20075—
+4K063249BeamaxMedic Sharplight, Ltd.200758—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+4K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+4K053324Chromolite SystemChromogenex Plc200631—
+4K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+4K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K040384Mydon CWavelight Laser Technologie AG200451—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K253765Vanish ProDdc Technologies, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—