510(k) Report

Devices descending from K922901

320 later devices reach Incisor I Pulsed ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+6K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K234085LUNE™ PureHygieneEnamel Pure20241—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K221761SoleaConvergent Dental, Inc.202201
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+6K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+6K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180508Joule SystemSciton, Inc20183—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K163128Epic ProBiolase, Inc.201716—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+6K123004Mira LasersMira Lasers, LLC20130—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K102639SL3Discus Dental, LLC201011
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K260138LUNE PureHygieneEnamel Pure20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172771Epic Pro 940Biolase, Inc.20171—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+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—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+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—
+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—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+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—
+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—