510(k) Report

Devices descending from K003202

759 later devices reach Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+7K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243488Vmat ProTermosalud20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K230077LaserMENeauvia North America20232—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K193266MIINMedico USA, Inc.20210—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K201406PicowonWontech Co., Ltd.20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K193426Elite iQCynosure, LLC20201—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192331LaseMD LEO Laser SystemLutronic Global20190—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K182173Joule SystemSciton, Inc20195—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K171009LASEMD Laser SystemLutronic Corporation20178—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—