510(k) Report

Devices descending from K973324

1,535 later devices reach Starlight Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+7K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+7K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+7K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+7K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+7K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K193201BTL-785FBtl20208—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+7K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+7K193426Elite iQCynosure, LLC20201—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181868SHINY RPL SystemIds, Ltd.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180338CellulizeWard Photonics, LLC20182—
+7K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K181659Avologi ENEOPremier North America, Inc.20184—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+7K180320dpl IIa PanelLed Technologies, Inc.201814—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K172111Vevazz LEDVevazz, LLC20170—
+7K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+7K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160821Tria SapphireTria Beauty, Inc.20160—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K143554Venus Legacy CXVenus Concept, Ltd.201517—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K141904Viora V-TouchViora, Ltd.20140—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+7K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+7K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+7K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+7K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K131758Surgen UPollogen, Ltd.20135—
+7K131839DC 7Dc International, LLC20130—
+7K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—