510(k) Report

Devices descending from K930856

760 later devices reach Psoralite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+5K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131758Surgen UPollogen, Ltd.20135—