510(k) Report

Devices descending from K033172

654 later devices reach Candela Gentleyag Family of Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K171648BM.IrisBluecore Co., Ltd.20172—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K161669Waterlase ExpressBiolase, Inc.201621—
+4K152737Lite TouchFocus Medical, LLC20160—
+4K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K142093V20 SystemViora, Ltd.201432—
+4K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K141555AdvantageLutronic Corporation201414—
+4K140837Lucid LYBio-Med USA, Inc.20140—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K123573Youlaser CO2 LaserQuanta System Spa201319—
+4K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K091115ECO2 Laser SystemLutronic Corporation200927—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+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—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243488Vmat ProTermosalud20250—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+5K232236EchoQuanta System Spa20230—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K223680Eneka ProTermosalud20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—