510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230293TheraFace MaskTherabody, Inc.202316—
+10K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+10K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+10K223805AgnesAgnes Medical Co., Ltd.20233—
+10K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+10K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+10K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+10K223540AvalancheLase FamilyFotona D.O.O.20230—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+10K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+10K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K213674CellFX SystemPulse Biosciences, Inc.20220—
+10K213267Dynamis Pro FamilyFotona D.O.O.20222—
+10K222075CellFX SystemPulse Biosciences, Inc.20220—
+10K221671CellFX® SystemPulse Biosciences, Inc.20220—
+10K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+10K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+10K221407truSculpt iDCutera, Inc.20222—
+10K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+10K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+10K213350mJOULE System and AccessoriesSciton, Inc20220—
+10K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+10K212155TheraFace LEDTheragun, Inc.202142—
+10K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+10K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+10K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+10K212107ReversoIntelis Instruments, Ltd.20211—
+10K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+10K212238TheraFace MicrocurrentTheragun, Inc.20210—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+10K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+10K203788DermaV Laser SystemLutronic Corporation202101
+10K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+10K202199BTL-899STBtl20216—
+10K193266MIINMedico USA, Inc.20210—
+10K202172StarWalkerFotona D.O.O.20203—
+10K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+10K201406PicowonWontech Co., Ltd.20200—
+10K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—
+10K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+10K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+10K200241TempSure SystemCynosure, LLC202013—
+10K192430Epic 980Biolase, Inc.20195—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+10K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+10K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+10K190443MMSphereGalactic Beauty, LLC201942—
+10K183156V-LaserWontech Co., Ltd.20193—
+10K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+10K181518Sebacia MicroparticlesSebacia, Inc.20180—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+10K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+10K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+10K173199PicoSure WorkstationCynosure, Inc.20189—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+10K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+10K170984LG Beauty Led MaskLg Electronics201793—
+10K162755PicocareWontech Co., Ltd.20179—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+10K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+10K170500SIROLaser Advance+Dentsply Sirona201721—
+10K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+10K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+10K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K161185LUCERNA Dental LaserViax Dental Lab20160—
+10K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+10K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+10K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+10K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+10K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+10K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+10K160691Acne Light Therapy WandZuko, Inc.201650—
+10K152856Helios IIILaseroptek Co., Ltd.20165—
+10K160480PicoSure WorkstationCynosure, Inc.201620—
+10K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+10K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+10K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+10K150326PicoWay Laser SystemCandela Corporation201568—
+10K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+10K143105Picosure WorkstationCynosure, Inc.201549—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—