510(k) Report

Devices descending from K971737

1,000 later devices reach Cynosure Photogenica Lpir Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083008CoolskinElbio Co., Ltd.20092—
+5K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K080735CryominiZimmer Elektromedizin GmbH20081—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K072906SILK'NHome Skinovations, Ltd.2008169—
+5K072344Apl Medical SystemBios S.R.L.20076—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K052354Oculase MDBiolase Technology, Inc.20065—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+5K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250384IPL400El Global Trade, Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K230090Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd.20230—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K223680Eneka ProTermosalud20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213594Echolaser X4Elesta S.P.A20221—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—