510(k) Report

Devices descending from K931783

333 later devices reach Aesop (Automated Endoscopic System for Optimal Pos through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191678IP ConverterSony Electronics, Inc.20200—
+6K191328Megadyne Foot SwitchMegadyne Medical Products, Inc.20190—
+6K181258ConnectedOR Hub with Device and Voice ControlStryker201810—
+6K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+6K173285Joule SystemSciton, Inc20185—
+6K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+6K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+6K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K231126Eblator DeviceE Surgical, LLC20231—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K212055Connected OR Hub with Device and Voice ControlStryker Corporation20216—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlStryker20208—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192172Connected OR Hub with Device and Voice ControlStryker20199—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K180508Joule SystemSciton, Inc20183—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+7K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K141237Harmony LiteAlma, Inc.20154—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K230308Alma HarmonyAlma Lasers, Inc.20232—
+8K223680Eneka ProTermosalud20230—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Endoscopy20224—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K220108SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy20225—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—