510(k) Report

Devices descending from K800617

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K152714Quanta ForteQuanta System Spa201513—
+7K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151629Guardian 1000Quanta System Spa20150—
+7K143554Venus Legacy CXVenus Concept, Ltd.201517—
+7K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+7K143559XP1000 RFBTL Industries, Inc.20157—
+7K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150035V10 systemViora, Ltd.201531—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K141904Viora V-TouchViora, Ltd.20140—
+7K140120EPIC 10Biolase, Inc.20141—
+7K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+7K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133837Viora V-TotalViora, Ltd.201433—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K131758Surgen UPollogen, Ltd.20135—
+7K130459Tria Fan SystemTria Beauty, Inc.20131—
+7K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+7K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+7K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K122579VelashapeSyneron Medical, Ltd.20124—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+7K101321Ematrix CO2Syneron Medical, Ltd.20102—
+7K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+7K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+7K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K083629SmoothshapesEleme Medical, Inc.200927—
+7K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+7K082938EzlaseBiolase Technology, Inc.200850—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+7K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+7K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+8K261473ChromixTermosalud S.L.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250165PastelleWontech Co., Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—