510(k) Report

Devices descending from K042630

402 later devices reach Revlight Skin Care System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+1K101916Joule Multi-Platform SystemSciton, Inc2011111—
+1K092734E-Light LineEspansione Marketing S.P.A20102—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K060792IllumimedPhotoactif, LLC2006115—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K192856MT OneM&T S.R.L.20202—
+2K193656SkyPulseFotona D.O.O.202011—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K173285Joule SystemSciton, Inc20185—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+2K132976AdvatxAdvalight Aps20141—
+2K124064Young AgainEspansione Marketing S.P.A20131—
+2K122237Biophotas LifelightBiophotas, Inc.201371—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111286Quasar CalypsoSilver Bay, LLC201276—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K250189AdvaTxAdvalight Aps20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K234057NirvanaEl.En S.P.A.20240—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K22079410PLTentech Co., Ltd.20220—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K210183Waterlase iPLusBiolase, Inc.20220—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K202955Contour Light CL-100Contour Research, LLC20218—
+3K200616E>EyeCE-Swin20200—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K180508Joule SystemSciton, Inc20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K172413MT ONEM&T S.R.L.20175—
+3K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+3K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+3K152280BioPhotas Celluma3Biophotas, Inc.201649—
+3K152714Quanta ForteQuanta System Spa201513—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K131113Biophotas CellumaBiophotas, Inc.201455—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—