510(k) Report

Devices descending from K960772

1,286 later devices reach Photoderm PL. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K210084SilkroHironic Co., Ltd.20223—
+7K213261EpilMENeauvia North America20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+7K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K212238TheraFace MicrocurrentTheragun, Inc.20210—
+7K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+7K201111GentleMax Pro PlusCandela Corporation20203—
+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—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K190443MMSphereGalactic Beauty, LLC201942—
+7K183452Vbeam Prima Laser SystemCandela Corp.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—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K180224Element-TLElemenic Co., Ltd.20180—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K171262TempSureCynosure, Inc.201716—
+7K170984LG Beauty Led MaskLg Electronics201793—
+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—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+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—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161981Olive PlusAma Network, Inc.20160—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161661Thermi RF AccessoriesThermi20163—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K160470SculpSureCynosure, Inc.201620—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160691Acne Light Therapy WandZuko, Inc.201650—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K151793InMode RF SystemInmode MD, Ltd.20161—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131839DC 7Dc International, LLC20130—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K111689StlaseDental Photonics, Inc.201222—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—