510(k) Report

Devices descending from K921884

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K142372Pico Way Laser SystemCandela Corpation201470—
+10K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+10K140719Picosure WorkstationCynosure, Inc.201450—
+10K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+10K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+10K131839DC 7Dc International, LLC20130—
+10K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+10K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+10K130465EPIC 10SBiolase Technology, Inc.20130—
+10K111689StlaseDental Photonics, Inc.201222—
+11K252723Dynamis Pro FamilyFotona D.O.O.20260—
+11K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+11K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+11K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+11K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+11K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+11K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+11K253342PICO-KSpeclipse, Inc.20251—
+11K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+11K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+11K251730LIA Console (542-7)Leadoptik, Inc.20250—
+11K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+11K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+11K253344Bellus-QSpeclipse, Inc.20250—
+11K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+11K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+11K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+11K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+11K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+11K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K251094Alma VeilWontech Co., Ltd.20250—
+11K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+11K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+11K243587PureLift GLOWXtreem Pulse, LLC20251—
+11K250281Deka LotusEl.En S.P.A.20250—
+11K243330LYMA Laser PROLyma Life, Ltd.20250—
+11K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+11K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+11K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+11K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+11K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+11K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+11K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+11K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+11K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+11K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+11K232106Air Gap FiberWontech Co., Ltd.20240—
+11K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+11K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+11K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+11K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+11K223110truSculpt iDCutera, Inc.20221—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K221427V-LaserWontech Co., Ltd.20222—
+11K212663Helios IV 785Laseroptek Co., Ltd.20223—
+11K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K212891TempSure SystemCynosure, LLC20221—
+11K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+11K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+11K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+11K211107BTL-899 FPBTL Industries, Inc.20213—
+11K210948Omnilux CLEARGlobalmed Technologies202139—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K210226PicoSure WorkstationCynosure, LLC20213—
+11K200693K2 MobileHulaser, Inc.20202—
+11K202041Opera EvoQuanta System Spa20200—
+11K193486Epic 980Biolase, Inc.20202—
+11K193426Elite iQCynosure, LLC20201—