510(k) Report

Devices descending from K974536

1,496 later devices reach Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+7K202780SectumNeauvia North America20211—
+7K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+7K201111GentleMax Pro PlusCandela Corporation20203—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K200110SANDRO DualWontech Co., Ltd.20202—
+7K193486Epic 980Biolase, Inc.20202—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+7K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+7K192224BTL-899Btl20198—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K183452Vbeam Prima Laser SystemCandela Corp.20191—
+7K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K180406Ellipse YdunEllipse A/S20180—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+7K171262TempSureCynosure, Inc.201716—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K172004truSculptCutera, Inc.20173—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+7K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+7K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+7K161981Olive PlusAma Network, Inc.20160—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+7K161661Thermi RF AccessoriesThermi20163—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+7K160470SculpSureCynosure, Inc.201620—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+7K151793InMode RF SystemInmode MD, Ltd.20161—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+7K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+7K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+7K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+7K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131839DC 7Dc International, LLC20130—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K123889Acleara, TheraclearTheravant Corporation20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—