510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K193201BTL-785FBtl20208—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171648BM.IrisBluecore Co., Ltd.20172—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+8K160312Fraxis DuoIlooda Co,., Ltd.201614—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+8K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+8K140837Lucid LYBio-Med USA, Inc.20140—
+8K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+8K133364Picosure WorkstationCynosure, Inc.201451—
+8K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+8K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+8K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+8K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+8K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+8K123573Youlaser CO2 LaserQuanta System Spa201319—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+8K121346Picosure WorkstationCynosure, Inc.201287—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+8K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+8K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+8K091115ECO2 Laser SystemLutronic Corporation200927—
+8K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+8K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+8K090525Loi SystemPalomar Medical Products, Inc.20099—
+8K080932Mosaic Laser SystemLutronic Corporation20086—
+8K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+8K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+9K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K243488Vmat ProTermosalud20250—
+9K241270BTL-754BTL Industries, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K230077LaserMENeauvia North America20232—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K221865BTL-094BTL Industries, Inc.20230—
+9K210166Omnispec ED1000Medispec, Ltd.20230—
+9K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+9K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+9K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K212082PicoreBio-Med USA, Inc.20210—
+9K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+9K193266MIINMedico USA, Inc.20210—
+9K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K201406PicowonWontech Co., Ltd.20200—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—