510(k) Report

Devices descending from K941841

1,178 later devices reach Smartscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121435Silkn BlueHome Skinovations, Ltd.2013125—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110301Silk'n FXHome Skinovations, Ltd.201166—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K103415Tanda MaxPharos Life Corporation20110—
+5K100628PlasmaluxlsDaavlin Distributing Co.20100—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+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—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K093168Mediflash and EsteflashDermeo20100—
+5K090744CLAROClrs Technology Corporation20101—
+5K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+5K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+5K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+5K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+5K090724OR-LightYperion Technology20090—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083730IsolazAesthera Corporation20093—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+5K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+5K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K063249BeamaxMedic Sharplight, Ltd.200758—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+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—
+5K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+5K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+5K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+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—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+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—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—