510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183247dpl FacewareLed Technologies, Inc.201910—
+5K182173Joule SystemSciton, Inc20195—
+5K183118dpl SpotLiteLed Technologies, Inc.201922—
+5K180875Poly RejuvMedtek Skincare, LLC20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+5K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+5K1718212 Face / Face EvolutionHeat IN A Click201858—
+5K180406Ellipse YdunEllipse A/S20180—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K170068Softcure 96Wellray Medical Laser, Inc.20170—
+5K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+5K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+5K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K123889Acleara, TheraclearTheravant Corporation20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K102461FractoraInvasix, Ltd.201124—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+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—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+6K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+6K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+6K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+6K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+6K252187Aura Glide (FC40)Aura Medical, LLC20250—
+6K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251843Erchonia EVRLErchonia Corporation20250—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—