510(k) Report

Devices descending from K020697

229 later devices reach Depilase Twin Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241656Eneka SelectifTermosalud20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K232236EchoQuanta System Spa20230—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192856MT OneM&T S.R.L.20202—
+6K193656SkyPulseFotona D.O.O.202011—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191086ExciplexClarteis20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172413MT ONEM&T S.R.L.20175—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K131839DC 7Dc International, LLC20130—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K22079410PLTentech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631