510(k) Report

Devices descending from K011092

1,127 later devices reach Candela SPTL-1E Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+3K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+3K043032Dealight IplEuropro, Inc.20050—
+3K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+3K051255Lumiphase-ROpusmed, Inc.2005143—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+3K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+3K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K040156Ifl Professional System, Model C100Cyden Limited20040—
+3K033933Powerlite 600 EX SystemPreswede AB20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K033331Candela Cbeam Pulse Dye Laser SystemCandela Corp.2004230—
+3K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+3K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+3K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+3K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K023881Profile 1064 Laser SystemSciton, Inc2003227—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203054FlexSysGme German Medical Engineering GmbH20210—
+4K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200616E>EyeCE-Swin20200—
+4K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191693BC-5Reveallux, Corp20190—
+4K183708Poly ClearMedtek Skincare, LLC201922—
+4K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+4K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+4K180508Joule SystemSciton, Inc20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K171227StarWalkerFotona D.O.O.20177—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K152790Venus Versa SystemVenus Concept, Ltd.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152012EVO platformQuanta System Spa201537—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K140386Lumina 24Rogers Sciences, Inc.20150—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K141555AdvantageLutronic Corporation201414—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—