510(k) Report

Devices descending from K971874

816 later devices reach Sharplan Epitouch Alexandrite Laser System (5000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K211444CellFX SystemPulse Biosciences, Inc.20213—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+9K193201BTL-785FBtl20208—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+9K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+9K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+9K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+9K171648BM.IrisBluecore Co., Ltd.20172—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+9K160312Fraxis DuoIlooda Co,., Ltd.201614—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K153717Venus Versa SystemVenus Concept, Ltd.20161—
+9K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+9K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+9K140837Lucid LYBio-Med USA, Inc.20140—
+9K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+9K133364Picosure WorkstationCynosure, Inc.201451—
+9K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+9K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+9K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+9K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+9K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+9K123573Youlaser CO2 LaserQuanta System Spa201319—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+9K121346Picosure WorkstationCynosure, Inc.201287—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+9K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+9K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+9K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+9K091115ECO2 Laser SystemLutronic Corporation200927—
+9K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+9K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+9K090525Loi SystemPalomar Medical Products, Inc.20099—
+9K080932Mosaic Laser SystemLutronic Corporation20086—
+9K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+9K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+10K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K243488Vmat ProTermosalud20250—
+10K241270BTL-754BTL Industries, Inc.20251—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+10K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+10K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+10K230077LaserMENeauvia North America20232—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+10K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+10K221865BTL-094BTL Industries, Inc.20230—
+10K210166Omnispec ED1000Medispec, Ltd.20230—
+10K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K213674CellFX SystemPulse Biosciences, Inc.20220—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K222075CellFX SystemPulse Biosciences, Inc.20220—
+10K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+10K221671CellFX® SystemPulse Biosciences, Inc.20220—
+10K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+10K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+10K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+10K211639BTL-785WBTL Industries, Inc.20227—
+10K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+10K212107ReversoIntelis Instruments, Ltd.20211—
+10K212082PicoreBio-Med USA, Inc.20210—
+10K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+10K193266MIINMedico USA, Inc.20210—
+10K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+10K202041Opera EvoQuanta System Spa20200—