510(k) Report

Devices descending from K963947

1,546 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+8K193486Epic 980Biolase, Inc.20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192224BTL-899Btl20198—
+8K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K190743Venus BlissVenus Concept USA, Inc.20194—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K183247dpl FacewareLed Technologies, Inc.201910—
+8K183118dpl SpotLiteLed Technologies, Inc.201922—
+8K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K180875Poly RejuvMedtek Skincare, LLC20180—
+8K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+8K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+8K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+8K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+8K1718212 Face / Face EvolutionHeat IN A Click201858—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+8K171262TempSureCynosure, Inc.201716—
+8K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+8K172004truSculptCutera, Inc.20173—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+8K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+8K170068Softcure 96Wellray Medical Laser, Inc.20170—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+8K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+8K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+8K161981Olive PlusAma Network, Inc.20160—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+8K161661Thermi RF AccessoriesThermi20163—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+8K160470SculpSureCynosure, Inc.201620—
+8K152731XP1100 RFBTL Industries, Inc.20160—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+8K151793InMode RF SystemInmode MD, Ltd.20161—
+8K151629Guardian 1000Quanta System Spa20150—
+8K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+8K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+8K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+8K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+8K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131839DC 7Dc International, LLC20130—
+8K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+8K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K123889Acleara, TheraclearTheravant Corporation20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K111501I-Lipo SystemChromogenex Technologies Limited201215—
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+8K094049Stlase Diode LaserDental Photonics, Inc.201023—
+8K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+9K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…Shenzhen Xiazhifeng Electronic Co., Ltd.20260—
+9K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—