510(k) Report

Devices descending from K003993

705 later devices reach Dornier Medilas D Skinpulse Laser System (Skinpulse) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K242241SunnyShenB Co., Ltd.20250—
+7K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240248Volnewmer™Classys, Inc.20241—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K234085LUNE™ PureHygieneEnamel Pure20241—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K23299210THERMATentech, Inc.20230—
+7K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+7K232236EchoQuanta System Spa20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K230663DensityJeisys Medical, Inc.20232—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K221989The OligioWontech Co., Ltd.20222—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+7K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+7K193266MIINMedico USA, Inc.20210—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+7K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172771Epic Pro 940Biolase, Inc.20171—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K163415SlimShape SystemSyneron Medical, Ltd.201714—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162512truSculptCutera, Inc.20165—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K143559XP1000 RFBTL Industries, Inc.20157—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143109XP300BTL Industries, Inc.20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K130689Symphony RF GeneratorThermigen, Inc.201311—
+7K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253504Volnewmer™Classys, Inc.20260—
+8K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+8K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+8K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—