510(k) Report

Devices descending from K033549

679 later devices reach Starlux Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242349FoLixLumenis Be, Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K241406LavieenWontech Co., Ltd.20242—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K232236EchoQuanta System Spa20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+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—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K221873NeoGen PSR SystemEnergist Limited20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K192430Epic 980Biolase, Inc.20195—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K171702Exciplex308nmClarteis20175—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131839DC 7Dc International, LLC20130—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+6K111689StlaseDental Photonics, Inc.201222—
+6K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—