510(k) Report

Devices descending from K960032

1,152 later devices reach Coherent Versapulse Aesthetic Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+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—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+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—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110301Silk'n FXHome Skinovations, Ltd.201166—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K102461FractoraInvasix, Ltd.201124—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K103415Tanda MaxPharos Life Corporation20110—
+4K100628PlasmaluxlsDaavlin Distributing Co.20100—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K091467Baby QuasarSilver Bay, LLC20100—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K093168Mediflash and EsteflashDermeo20100—
+4K090744CLAROClrs Technology Corporation20101—
+4K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+4K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+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—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083730IsolazAesthera Corporation20093—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K063249BeamaxMedic Sharplight, Ltd.200758—
+4K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+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—
+4K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+4K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+4K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+4K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+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—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+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—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—