510(k) Report

Devices descending from K974381

1,178 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K113115Epicare YagLight Age, Inc.20120—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110301Silk'n FXHome Skinovations, Ltd.201166—
+5K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K103415Tanda MaxPharos Life Corporation20110—
+5K100628PlasmaluxlsDaavlin Distributing Co.20100—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K091467Baby QuasarSilver Bay, LLC20100—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K093168Mediflash and EsteflashDermeo20100—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K090744CLAROClrs Technology Corporation20101—
+5K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+5K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+5K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+5K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+5K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+5K090724OR-LightYperion Technology20090—
+5K091534Lightlas Model 532Lightmed Corp.200972—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K083008CoolskinElbio Co., Ltd.20092—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083730IsolazAesthera Corporation20093—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K080735CryominiZimmer Elektromedizin GmbH20081—
+5K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K072344Apl Medical SystemBios S.R.L.20076—
+5K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+5K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K063249BeamaxMedic Sharplight, Ltd.200758—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+5K053324Chromolite SystemChromogenex Plc200631—
+5K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+5K050218Wavelight SinonWavelight Laser Technologie AG20050—
+5K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+5K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K261674Skin Air Cooling System (QALF-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—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+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—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+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—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.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—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+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—
+6K241656Eneka SelectifTermosalud20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—