510(k) Report

Devices descending from K984110

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160691Acne Light Therapy WandZuko, Inc.201650—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140120EPIC 10Biolase, Inc.20141—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+8K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+8K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+8K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+8K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+8K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+8K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+8K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+8K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+8K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+8K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+8K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K244060eCO2 3DLutronic Corporation20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+8K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+8K243587PureLift GLOWXtreem Pulse, LLC20251—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243330LYMA Laser PROLyma Life, Ltd.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—