510(k) Report

Devices descending from K980420

1,494 later devices reach Lightsheer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K223110truSculpt iDCutera, Inc.20221—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+11K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+11K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+11K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+11K211107BTL-899 FPBTL Industries, Inc.20213—
+11K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+11K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+11K192970SlimusHironic Co., Ltd.20200—
+11K202041Opera EvoQuanta System Spa20200—
+11K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+11K200241TempSure SystemCynosure, LLC202013—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+11K171992SculpSureCynosure, Inc.20178—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K163128Epic ProBiolase, Inc.201716—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+11K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+11K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+11K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+12K262524Sapphire 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—
+12K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+12K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+12K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+12K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+12K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+12K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd.20250—
+12K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+12K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+12K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.20241—
+12K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+12K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+12K212891TempSure SystemCynosure, LLC20221—
+12K213344BTL-899ABTL Industries, Inc.20222—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+12K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+12K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+12K202503ChromeQuanta System Spa202012—
+12K182741SculpSureCynosure20195—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+13K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+13K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd.20250—
+13K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+13K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+13K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K223292TempSure SystemCynosure, LLC20220—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+14K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+14K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+14K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+15K172144CoolSculpting SystemZeltiq Aesthetics20177—
+16K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805