510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K190443MMSphereGalactic Beauty, LLC201942—
+10K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+10K182997enlighten III Laser SystemCutera, Inc.20180—
+10K182669Youlaser CO2Quanta System Spa20181—
+10K181272Picocare FamilyWontech Co., Ltd.20188—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K173503Pollogen Legend SystemPollogen, Ltd.20183—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K170984LG Beauty Led MaskLg Electronics201793—
+10K172096FraxisIlooda Co,., Ltd.20172—
+10K170325Secret RFIlooda Co,., Ltd.201710—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K160691Acne Light Therapy WandZuko, Inc.201650—
+10K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+10K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+10K150027CYMAWhitecap Technologies, LLC20150—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+10K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K132754Neogen PSR SystemEnergist, Ltd.20132—
+10K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K110375Blueshine's Gold SeriesBlueshine Srl20124—
+10K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+10K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+10K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+10K082938EzlaseBiolase Technology, Inc.200850—
+10K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+10K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+10K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+11K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+11K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+11K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+11K261570Picosure WorkstationCynosure, LLC20260—
+11K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+11K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+11K251981Boston PICO (Boston PICO)Boston Aesthetics, 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—
+11K252369Boston Pico755Boston Aesthetics, Inc.20260—
+11K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+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—
+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—
+11K253123CuRAS hybridClassys, 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—
+11K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+11K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+11K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+11K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+11K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, 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—
+11K244060eCO2 3DLutronic Corporation20250—
+11K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+11K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+11K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+11K243957PicoalexWontech Co., Ltd.20250—
+11K243587PureLift GLOWXtreem Pulse, LLC20251—
+11K243330LYMA Laser PROLyma Life, Ltd.20250—
+11K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+11K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+11K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+11K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+11K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K241406LavieenWontech Co., Ltd.20242—
+11K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+11K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+11K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+11K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+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—
+11K222556BTL-785XBTL Industries, Inc.20235—
+11K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+11K221873NeoGen PSR SystemEnergist Limited20230—
+11K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+11K220853PicoWay Laser SystemCandela Corporation20221—