510(k) Report

Devices descending from K033946

737 later devices reach Lovely System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+3K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K152280BioPhotas Celluma3Biophotas, Inc.201649—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K131758Surgen UPollogen, Ltd.20135—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+4K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—