510(k) Report

Devices descending from K853620

676 later devices reach Model XA-50 - CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, 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—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+8K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd.20210—
+8K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+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—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+8K192990Litho EvoQuanta System Spa20190—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+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—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+8K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+8K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+8K151629Guardian 1000Quanta System Spa20150—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K142289PK SpatulaGyrus Acmi, Inc.20141—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K133837Viora V-TotalViora, Ltd.201433—
+8K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+8K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+8K122493GenesisplusCutera, Inc.201318—
+8K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+8K121678DTADGyrus Acmi, Inc.20122—
+8K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+8K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+8K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+8K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+8K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+8K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+8K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+8K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+8K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+8K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+8K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K253007Laser 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—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—