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
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+6K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+6K1718212 Face / Face EvolutionHeat IN A Click201858—
+6K180406Ellipse YdunEllipse A/S20180—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170068Softcure 96Wellray Medical Laser, Inc.20170—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+6K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K152611V20 systemViora, Ltd.20164—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+6K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+6K150035V10 systemViora, Ltd.201531—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123889Acleara, TheraclearTheravant Corporation20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K102461FractoraInvasix, Ltd.201124—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+7K252187Aura Glide (FC40)Aura Medical, LLC20250—
+7K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251843Erchonia EVRLErchonia Corporation20250—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—