510(k) Report

Devices descending from K982940

1,526 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+9K243587PureLift GLOWXtreem Pulse, LLC20251—
+9K243330LYMA Laser PROLyma Life, Ltd.20250—
+9K250200InbellaBody SystemInbella Medical, Inc.20250—
+9K243929Oligio XWontech Co., Ltd.20250—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+9K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+9K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K241406LavieenWontech Co., Ltd.20242—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+9K232575Hair Removal Device, Model (s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd.20235—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K230167BACK 4Swims America Corp20230—
+9K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd.20238—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K230037BACK 3Swims America Corp20230—
+9K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+9K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+9K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+9K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+9K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K221407truSculpt iDCutera, Inc.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+9K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+9K210948Omnilux CLEARGlobalmed Technologies202139—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K202199BTL-899STBtl20216—
+9K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+9K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K190678TempSureCynosure, Inc.201914—
+9K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+9K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+9K182604New EraStep UP Skin Laser, LLC201801
+9K182365TempSure SystemCynosure, Inc.201815—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K171111SculpsureCynosure, Inc.201710—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170709CURVE Laser SystemYolo Medical, Inc.20170—
+9K170116Thermi Injectable RF ElectrodesThermi20172—
+9K163190InMode RF SystemInmode MD, Ltd.20160—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K111689StlaseDental Photonics, Inc.201222—
+10K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B…ONE BEAUTY Technology Co., Ltd.20260—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+10K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+10K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—