510(k) Report

Devices descending from K984110

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+4K153229SuperbiumBios S.R.L.20162—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K140386Lumina 24Rogers Sciences, Inc.20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121435Silkn BlueHome Skinovations, Ltd.2013125—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110301Silk'n FXHome Skinovations, Ltd.201166—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K103415Tanda MaxPharos Life Corporation20110—
+4K100628PlasmaluxlsDaavlin Distributing Co.20100—
+4K091467Baby QuasarSilver Bay, LLC20100—
+4K093168Mediflash and EsteflashDermeo20100—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090744CLAROClrs Technology Corporation20101—
+4K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+4K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K090399Trios SystemViora, Ltd.20090—
+4K083008CoolskinElbio Co., Ltd.20092—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083730IsolazAesthera Corporation20093—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K080735CryominiZimmer Elektromedizin GmbH20081—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+4K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+4K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+4K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243488Vmat ProTermosalud20250—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—