510(k) Report

Devices descending from K032220

126 later devices reach Adept 1064/532 Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062369Iridex Oculight TXIridex Corp200673—
+1K040384Mydon CWavelight Laser Technologie AG200451—
+2K170850Alma QAlma Lasers, Ltd.20172—
+2K091534Lightlas Model 532Lightmed Corp.200972—
+2K090762LEDAQuantel Derma GmbH200946—
+2K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K171702Exciplex308nmClarteis20175—
+4K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K140120EPIC 10Biolase, Inc.20141—
+4K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K191086ExciplexClarteis20194—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K131839DC 7Dc International, LLC20130—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+6K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+6K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+6K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—