510(k) Report

Devices descending from K800617

1,325 later devices reach Hyfrecator, #733 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+6K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+6K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+6K093465Fusion SystemEclipsemed Global, Inc.20100—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+6K090221Reaction SystemViora, Ltd.200954—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+6K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K081408Ellipse MultiflexEllipse A/S20087—
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+6K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+6K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+6K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+6K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+6K072394Portrait Stand-OffRhytec Incorporated2007104—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071872VelashapeSyneron Medical, Ltd.2007127—
+6K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+6K061603SmoothshapesBiocellulase, Inc.200648—
+6K053611SmoothshapesBicellulase, Inc.200695—
+6K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+6K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+6K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+6K041969Aurora DSSyneron Medical, Ltd.2004302—
+6K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K262364Ellian Enigma RF DeviceEllian Corp20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K253504Volnewmer™Classys, Inc.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K253750BTL-785NEHBTL Industries, Inc.20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250224handLITE (TN19S)iSMART Developments, 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—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K243488Vmat ProTermosalud20250—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+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—
+7K242532BTL-785BNF-EBTL Industries, Inc.20241—
+7K240897CellinewVIOL Co., Ltd.20240—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K231948MediyagMedicreations, LLC20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+7K240313Oligio XWontech Co., Ltd.20241—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+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—