510(k) Report

Devices descending from K000811

771 later devices reach Nlite System, SLS Model Number A00-1025 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+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—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K221873NeoGen PSR SystemEnergist Limited20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K201773PicohiHironic Co., Ltd.20215—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K193201BTL-785FBtl20208—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K193426Elite iQCynosure, LLC20201—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K182173Joule SystemSciton, Inc20195—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181868SHINY RPL SystemIds, Ltd.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K180224Element-TLElemenic Co., Ltd.20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K131839DC 7Dc International, LLC20130—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—