510(k) Report

Devices descending from K923575

484 later devices reach Coherent Versapluse 2.1 Holmium Surg. Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K131805Inpulse LaserIncisive, Inc.20130—
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K130413Pinpointe FootlaserNuvolase, Inc.20130—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K103338CooltouchNew Star Lasers, Inc.201101
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110370Q-ClearLight Age, Inc.201135—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+5K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+5K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+5K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+5K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+5K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp.20020—
+6K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+6K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+6K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+6K251824Patriot DuoPatriot Laser, LLC20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+6K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+6K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+6K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+6K192990Litho EvoQuanta System Spa20190—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K180508Joule SystemSciton, Inc20183—
+6K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+6K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142289PK SpatulaGyrus Acmi, Inc.20141—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+6K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+6K122493GenesisplusCutera, Inc.201318—
+6K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+6K121678DTADGyrus Acmi, Inc.20122—