510(k) Report

Devices descending from K955758

701 later devices reach Indigo Medical Model Idl 830E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K240248Volnewmer™Classys, Inc.20241—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K23299210THERMATentech, Inc.20230—
+8K232236EchoQuanta System Spa20230—
+8K231146AliTightAlic Iotech, LLC20230—
+8K230663DensityJeisys Medical, Inc.20232—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K221989The OligioWontech Co., Ltd.20222—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K193266MIINMedico USA, Inc.20210—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K202041Opera EvoQuanta System Spa20200—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K193486Epic 980Biolase, Inc.20202—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+8K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162512truSculptCutera, Inc.20165—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K152611V20 systemViora, Ltd.20164—
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K150035V10 systemViora, Ltd.201531—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K143109XP300BTL Industries, Inc.20150—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K130689Symphony RF GeneratorThermigen, Inc.201311—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253504Volnewmer™Classys, Inc.20260—
+9K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K240897CellinewVIOL Co., Ltd.20240—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K233473Deka LotusEl.En S.P.A.20241—