510(k) Report

Devices descending from K013043

703 later devices reach Candela Clearbeam Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K241656Eneka SelectifTermosalud20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K223680Eneka ProTermosalud20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K193266MIINMedico USA, Inc.20210—
+5K202172StarWalkerFotona D.O.O.20203—
+5K201406PicowonWontech Co., Ltd.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K192856MT OneM&T S.R.L.20202—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+5K180508Joule SystemSciton, Inc20183—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K161669Waterlase ExpressBiolase, Inc.201621—