510(k) Report

Devices descending from K972347

1,142 later devices reach Modified Coherent Versapulse Aesthetic Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K190443MMSphereGalactic Beauty, LLC201942—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K170984LG Beauty Led MaskLg Electronics201793—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160691Acne Light Therapy WandZuko, Inc.201650—
+8K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+8K150664NeoLasSheaumann Laser, Inc.20151—
+8K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+8K110375Blueshine's Gold SeriesBlueshine Srl20124—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+8K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K253712LED 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—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+9K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+9K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+9K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+9K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+9K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K244060eCO2 3DLutronic Corporation20250—
+9K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+9K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+9K243587PureLift GLOWXtreem Pulse, LLC20251—
+9K243330LYMA Laser PROLyma Life, Ltd.20250—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+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—
+9K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+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—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K232106Air Gap FiberWontech 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—