510(k) Report

Devices descending from K964736

979 later devices reach Bergen 610 Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+6K090744CLAROClrs Technology Corporation20101—
+6K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+6K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+6K093465Fusion SystemEclipsemed Global, Inc.20100—
+6K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+6K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+6K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+6K082938EzlaseBiolase Technology, Inc.200850—
+6K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K070004AccentAlma Lasers, Ltd.2007181—
+6K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+6K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+6K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+6K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K231948MediyagMedicreations, LLC20240—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K234057NirvanaEl.En S.P.A.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+7K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+7K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K22079410PLTentech Co., Ltd.20220—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K192621Medical RFTriworks Group Srl20200—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K200616E>EyeCE-Swin20200—
+7K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+7K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+7K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K183156V-LaserWontech Co., Ltd.20193—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180338CellulizeWard Photonics, LLC20182—