510(k) Report

Devices descending from K933362

1,220 later devices reach Sharplan CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+9K190678TempSureCynosure, Inc.201914—
+9K190743Venus BlissVenus Concept USA, Inc.20194—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+9K183247dpl FacewareLed Technologies, Inc.201910—
+9K183118dpl SpotLiteLed Technologies, Inc.201922—
+9K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+9K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K180875Poly RejuvMedtek Skincare, LLC20180—
+9K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+9K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+9K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+9K1718212 Face / Face EvolutionHeat IN A Click201858—
+9K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+9K171262TempSureCynosure, Inc.201716—
+9K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+9K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+9K171227StarWalkerFotona D.O.O.20177—
+9K172004truSculptCutera, Inc.20173—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K170068Softcure 96Wellray Medical Laser, Inc.20170—
+9K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+9K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+9K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+9K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+9K153717Venus Versa SystemVenus Concept, Ltd.20161—
+9K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+9K152611V20 systemViora, Ltd.20164—
+9K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+9K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+9K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+9K151629Guardian 1000Quanta System Spa20150—
+9K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+9K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+9K151655CO2RE SystemSyneron Medical, Ltd.20151—
+9K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+9K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+9K141868Tria FanpTria Beauty, Inc.20140—
+9K142093V20 SystemViora, Ltd.201432—
+9K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+9K140120EPIC 10Biolase, Inc.20141—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+9K133364Picosure WorkstationCynosure, Inc.201451—
+9K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+9K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+9K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+9K132754Neogen PSR SystemEnergist, Ltd.20132—
+9K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+9K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+9K121327Diolase 10SBiolase Technology, Inc.20132—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K121346Picosure WorkstationCynosure, Inc.201287—
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+9K111501I-Lipo SystemChromogenex Technologies Limited201215—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+9K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+9K094049Stlase Diode LaserDental Photonics, Inc.201023—
+9K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+10K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+10K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+10K253803MILAN SystemLumenis Be, Ltd.20260—
+10K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+10K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+10K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—