510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180383Light based hair removal deviceShenzhen Gsd Tech Co., Ltd.20181—
+6K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+6K180320dpl IIa PanelLed Technologies, Inc.201814—
+6K180016Home Use IPL Beauty DeviceShenzhen Mismon Technology Co., Ltd.201825—
+6K172883Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd.20180—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172111Vevazz LEDVevazz, LLC20170—
+6K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+6K171702Exciplex308nmClarteis20175—
+6K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+6K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+6K162784Silk'n HSTHome Skinovations, Ltd.20171—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017115—
+6K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K160368EVO platformQuanta System Spa201636—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K143554Venus Legacy CXVenus Concept, Ltd.201517—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K141904Viora V-TouchViora, Ltd.20140—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+6K120510TranscendSyneron Medical, Ltd.201318—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K122966XP200Btl Industries, Ltd.20131—
+6K123257Emvera DioluxEmvera Technologies, Inc.20123—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K122579VelashapeSyneron Medical, Ltd.20124—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—