510(k) Report

Devices descending from K051259

47 later devices reach Versaclear Skin Therapy System, Model 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090762LEDAQuantel Derma GmbH200946—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+2K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+2K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+2K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+3K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+3K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+3K171702Exciplex308nmClarteis20175—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+4K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+4K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+4K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+4K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+4K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+4K233224Epilaser ProEpilady 2000, LLC20240—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+4K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K191086ExciplexClarteis20194—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+5K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+5K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—