510(k) Report

Devices descending from K001527

365 later devices reach Fotona Fidelis ER: Yag Laser System and Accesories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K073411LiteduoLight Instruments20081—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K243488Vmat ProTermosalud20250—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K173285Joule SystemSciton, Inc20185—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132976AdvatxAdvalight Aps20141—
+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—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K253123CuRAS hybridClassys, Inc.20250—
+7K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+7K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—