510(k) Report

Devices descending from K912029

676 later devices reach Ultrapulse (TM) Carbon Dioxide Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K152714Quanta ForteQuanta System Spa201513—
+7K151629Guardian 1000Quanta System Spa20150—
+7K142289PK SpatulaGyrus Acmi, Inc.20141—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133837Viora V-TotalViora, Ltd.201433—
+7K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+7K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K122493GenesisplusCutera, Inc.201318—
+7K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+7K121678DTADGyrus Acmi, Inc.20122—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+7K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+7K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+7K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+7K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+7K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+7K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+7K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+7K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+7K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+7K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.20260—
+8K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+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—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K250998CO2 Laser Therapy System (Model: LFS-D9U)Sanhe Lefis Electronics Co., Ltd.20250—
+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—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+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—
+8K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+8K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+8K232236EchoQuanta System Spa20230—
+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—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd.20210—
+8K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202172StarWalkerFotona D.O.O.20203—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+8K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172413MT ONEM&T S.R.L.20175—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170908PK AIMGyrus Acmi, Inc.20170—
+8K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+8K161038PK MorcellatorGyrus Acmi, Inc.20160—
+8K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+8K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+8K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—