510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+8K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+8K202780SectumNeauvia North America20211—
+8K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+8K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+8K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+8K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+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—
+8K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+8K201111GentleMax Pro PlusCandela Corporation20203—
+8K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K200110SANDRO DualWontech Co., Ltd.20202—
+8K193486Epic 980Biolase, Inc.20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+8K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+8K192224BTL-899Btl20198—
+8K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+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—
+8K183452Vbeam Prima Laser SystemCandela Corp.20191—
+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—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+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—
+8K180406Ellipse YdunEllipse A/S20180—
+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—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+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—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+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—