510(k) Report

Devices descending from K984110

1,034 later devices reach Laserscope Coolspot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+5K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K200616E>EyeCE-Swin20200—
+5K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K180338CellulizeWard Photonics, LLC20182—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K181659Avologi ENEOPremier North America, Inc.20184—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+5K180508Joule SystemSciton, Inc20183—
+5K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+5K180320dpl IIa PanelLed Technologies, Inc.201814—
+5K173285Joule SystemSciton, Inc20185—
+5K172111Vevazz LEDVevazz, LLC20170—
+5K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+5K171702Exciplex308nmClarteis20175—
+5K172413MT ONEM&T S.R.L.20175—
+5K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+5K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+5K162784Silk'n HSTHome Skinovations, Ltd.20171—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+5K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K152714Quanta ForteQuanta System Spa201513—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+5K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+5K140471Pro X Otc 5La Lumiere, LLC2015107—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K101415TheraclearTheravant Corporation20101—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—