510(k) Report

Devices descending from K020339

695 later devices reach Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193486Epic 980Biolase, Inc.20202—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K200234Surgical laser fibersQuanta System Spa20202—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180044SIROLaser BlueDentsply Sirona201812—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172771Epic Pro 940Biolase, Inc.20171—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K163197Cook Holmium Laser FiberCook Incorporated20170—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162512truSculptCutera, Inc.20165—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143109XP300BTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K130689Symphony RF GeneratorThermigen, Inc.201311—
+6K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K253504Volnewmer™Classys, Inc.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253750BTL-785NEHBTL Industries, Inc.20260—
+7K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+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—
+7K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+7K242532BTL-785BNF-EBTL Industries, Inc.20241—
+7K240897CellinewVIOL Co., Ltd.20240—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K234085LUNE™ PureHygieneEnamel Pure20241—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K240313Oligio XWontech Co., Ltd.20241—
+7K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+7K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+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—