510(k) Report

Devices descending from K983054

748 later devices reach Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—