510(k) Report

Devices descending from K973354

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K083008CoolskinElbio Co., Ltd.20092—
+5K080735CryominiZimmer Elektromedizin GmbH20081—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+6K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+6K22079410PLTentech Co., Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213594Echolaser X4Elesta S.P.A20221—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K171227StarWalkerFotona D.O.O.20177—
+6K160368EVO platformQuanta System Spa201636—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K160470SculpSureCynosure, Inc.201620—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+11K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+11K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K202503ChromeQuanta System Spa202012—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K171111SculpsureCynosure, Inc.201710—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K240752Deka ToroEl.En S.P.A.20240—
+12K233473Deka LotusEl.En S.P.A.20241—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—