510(k) Report

Devices descending from K980537

1,242 later devices reach ND: Yag Accessory for Photoderm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+8K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+8K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+8K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K244060eCO2 3DLutronic Corporation20250—
+8K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+8K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K243587PureLift GLOWXtreem Pulse, LLC20251—
+8K243330LYMA Laser PROLyma Life, Ltd.20250—
+8K250200InbellaBody SystemInbella Medical, Inc.20250—
+8K243929Oligio XWontech Co., Ltd.20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K241406LavieenWontech Co., Ltd.20242—
+8K233123SilkroHironic Co., Ltd.20241—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+8K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+8K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221407truSculpt iDCutera, Inc.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+8K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K210948Omnilux CLEARGlobalmed Technologies202139—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K202199BTL-899STBtl20216—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K193486Epic 980Biolase, Inc.20202—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K190678TempSureCynosure, Inc.201914—
+8K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+8K182365TempSure SystemCynosure, Inc.201815—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K170116Thermi Injectable RF ElectrodesThermi20172—
+8K163128Epic ProBiolase, Inc.201716—
+8K163190InMode RF SystemInmode MD, Ltd.20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—