510(k) Report

Devices descending from K032460

569 later devices reach Profile BBL System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+1K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+1K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+1K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+1K081578Accela SystemGenesis Biosystems, Inc.20080—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+1K060033Profile Multi-Platform SystemSciton, Inc2006221—
+1K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+1K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K221571InMode Multi-systemInMode, Ltd.20222—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K141975Waterlase Iplus SBiolase, Inc.20150—
+2K130459Tria Fan SystemTria Beauty, Inc.20131—
+2K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+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—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+2K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+2K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+2K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+2K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+2K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+2K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+2K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K251632Optimas MAX SystemInMode, 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—
+3K234057NirvanaEl.En S.P.A.20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K200616E>EyeCE-Swin20200—
+3K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172413MT ONEM&T S.R.L.20175—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K152714Quanta ForteQuanta System Spa201513—
+3K141868Tria FanpTria Beauty, Inc.20140—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+3K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+3K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+3K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282