510(k) Report

Devices descending from K972347

1,142 later devices reach Modified Coherent Versapulse Aesthetic Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+1K001589Candela Dynamic Cooling DeviceCandela Corp.20001,064—
+1K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+2K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+2K014253Dermachiller 4Paradigm Trex, LLC200250—
+2K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K151337StrialiteCentre Light Solutions, LLC20160—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K102461FractoraInvasix, Ltd.201124—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+3K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+3K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+3K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+3K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+3K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+3K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—