510(k) Report

Devices descending from K984110

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241406LavieenWontech Co., Ltd.20242—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+8K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+8K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K210948Omnilux CLEARGlobalmed Technologies202139—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192430Epic 980Biolase, Inc.20195—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K160470SculpSureCynosure, Inc.201620—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K160368EVO platformQuanta System Spa201636—
+8K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+8K152012EVO platformQuanta System Spa201537—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K150724SculpSureCynosure, Inc.201521—
+8K150230SculpSureCynosure, Inc.201521—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K131839DC 7Dc International, LLC20130—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K111689StlaseDental Photonics, Inc.201222—
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—