510(k) Report

Devices descending from K921884

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+7K072394Portrait Stand-OffRhytec Incorporated2007104—
+7K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+7K071872VelashapeSyneron Medical, Ltd.2007127—
+7K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+7K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K061603SmoothshapesBiocellulase, Inc.200648—
+7K053611SmoothshapesBicellulase, Inc.200695—
+7K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+7K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+7K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+7K041969Aurora DSSyneron Medical, Ltd.2004302—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K262364Ellian Enigma RF DeviceEllian Corp20260—
+8K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+8K253504Volnewmer™Classys, Inc.20260—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+8K250189AdvaTxAdvalight Aps20250—
+8K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+8K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+8K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+8K243488Vmat ProTermosalud20250—
+8K240311JETT Medical IICompex, Spol, S.R.O.20250—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+8K240897CellinewVIOL Co., Ltd.20240—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+8K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+8K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+8K240313Oligio XWontech Co., Ltd.20241—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+8K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+8K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+8K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+8K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K22079410PLTentech Co., Ltd.20220—
+8K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K213612Sylfirm XVIOL Co., Ltd.20221—
+8K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K210183Waterlase iPLusBiolase, Inc.20220—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K211562Virtue RFShenB Co., Ltd.20212—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K203299CellFX SystemPulse Biosciences, Inc.20214—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200616E>EyeCE-Swin20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—