510(k) Report

Devices descending from K885025

333 later devices reach Houva II Uva through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+1K022165Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc.2002291—
+2K091568LH-75 Phototherapy SystemLerner Medical Devices, Inc.20090—
+2K090762LEDAQuantel Derma GmbH200946—
+2K090097LH-75T Phototherapy SystemLerner Medical Devices, Inc.20097—
+2K072035Resolve Uvb Phototherapy SystemAllux Medical20076—
+2K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc200732
+2K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc.2005274—
+2K040062Levia Phototherapy SystemLerner Medical Devices, Inc.2004280—
+2K024020Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc.2003289—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20172—
+3K171702Exciplex308nmClarteis20175—
+3K170489Skylit Phototherapy SystemSkylit Medical20175—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K103540Psoria-LightPsoria-Shield, Inc.20113—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K073066308 Dermatological Excimer SystemQuantel Medical, Inc.20076—
+4K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+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—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K192411Psoria-Shield AURORAPsoria-Shield20202—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20201—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191086ExciplexClarteis20194—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173436Luma Light SystemLuma Therapeutics20183—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K153229SuperbiumBios S.R.L.20162—
+4K141237Harmony LiteAlma, Inc.20154—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+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—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K230076Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc.20230—
+5K223588PALLAS PremiumLaseroptek Co., Ltd.20230—
+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—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K200616E>EyeCE-Swin20200—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172413MT ONEM&T S.R.L.20175—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+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—