510(k) Report

Devices descending from K984552

1,174 later devices reach Cool-Tip RF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+7K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+7K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+7K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+7K141868Tria FanpTria Beauty, Inc.20140—
+7K142093V20 SystemViora, Ltd.201432—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140120EPIC 10Biolase, Inc.20141—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111501I-Lipo SystemChromogenex Technologies Limited201215—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+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—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K254185Potenza PrimeJeisys Medical Incorporated20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+8K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+8K253803MILAN SystemLumenis Be, Ltd.20260—
+8K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+8K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+8K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+8K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+8K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+8K251254Ignite RF SystemInMode, Ltd.20260—
+8K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+8K252187Aura Glide (FC40)Aura Medical, LLC20250—
+8K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K252367InbellaMulti SystemInbella Medical, Inc.20250—
+8K251334New Doublo 2.0Hironic 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—
+8K251843Erchonia EVRLErchonia Corporation20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+8K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250200InbellaBody SystemInbella Medical, Inc.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+8K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—
+8K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+8K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—