510(k) Report

Devices descending from K941312

679 later devices reach Sharplan Swiftlase 765/766/767 Flashscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180423Empower H65Quanta System Spa20181—
+7K171227StarWalkerFotona D.O.O.20177—
+7K163449HyPHo Laser SystemHyper Photonics Srl20170—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+7K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+7K170331Cyber HoQuanta System Spa20179—
+7K163009LithoQuanta System Spa201612—
+7K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152714Quanta ForteQuanta System Spa201513—
+7K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+7K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+7K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+7K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+7K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K110685Flexiva TractipBoston Scientific Corp20112—
+7K110686AccutracBoston Scientific Corp20110—
+7K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+7K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+7K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+7K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+7K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+7K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+7K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.20260—
+8K260100MOSES Raydar™Boston Scientific Corporation20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260257CO2 Laser SystemSanhe Meditech Co., Ltd.20260—
+8K253920CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd.20260—
+8K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K250998CO2 Laser Therapy System (Model: LFS-D9U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K232236EchoQuanta System Spa20230—
+8K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K213252Dornier ThulioDornier Medtech America, Inc.20220—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd.20210—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202172StarWalkerFotona D.O.O.20203—
+8K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—