510(k) Report

Devices descending from K904427

283 later devices reach Panosol II Uvb-206 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111049Mobile Versa LightMedtek Lighting Corp20121—
+1K040062Levia Phototherapy SystemLerner Medical Devices, Inc.2004280—
+2K170489Skylit Phototherapy SystemSkylit Medical20175—
+2K134009UV Biotek Single Panel, UV Biotek Multi-DirectionalMedtek Lighting20140—
+2K090097LH-75T Phototherapy SystemLerner Medical Devices, Inc.20097—
+2K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc.2005274—
+3K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+3K173436Luma Light SystemLuma Therapeutics20183—
+3K171702Exciplex308nmClarteis20175—
+3K091568LH-75 Phototherapy SystemLerner Medical Devices, Inc.20090—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K073066308 Dermatological Excimer SystemQuantel Medical, Inc.20076—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191086ExciplexClarteis20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K153229SuperbiumBios S.R.L.20162—
+4K141237Harmony LiteAlma, Inc.20154—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K200616E>EyeCE-Swin20200—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172413MT ONEM&T S.R.L.20175—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K152714Quanta ForteQuanta System Spa201513—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+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—
+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—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+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—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—