510(k) Report

Devices descending from K955621

677 later devices reach Sharplan Lasers, Inc Silktouch 2 Flash Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K180426Empower H35Quanta System Spa20181—
+7K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+7K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+7K172413MT ONEM&T S.R.L.20175—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172025Litho 60Quanta System Spa20178—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+7K131805Inpulse LaserIncisive, Inc.20130—
+7K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+7K130413Pinpointe FootlaserNuvolase, Inc.20130—
+7K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+7K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+7K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+7K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+7K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+7K110375Blueshine's Gold SeriesBlueshine Srl20124—
+7K111483Joule Clearsense Laser SystemSciton, Inc20110—
+7K103338CooltouchNew Star Lasers, Inc.201101
+7K110370Q-ClearLight Age, Inc.201135—
+7K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+7K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+7K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+7K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+7K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+7K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+7K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+7K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp.20020—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+8K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+8K251824Patriot DuoPatriot Laser, LLC20250—
+8K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K212472AgeJetTriworks Group Srl20220—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+8K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+8K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K192990Litho EvoQuanta System Spa20190—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+8K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+8K151629Guardian 1000Quanta System Spa20150—
+8K142289PK SpatulaGyrus Acmi, Inc.20141—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K133837Viora V-TotalViora, Ltd.201433—