510(k) Report

Devices descending from K030142

773 later devices reach Thermacool TC System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K202780SectumNeauvia North America20211—
+4K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+4K190743Venus BlissVenus Concept USA, Inc.20194—
+4K183450EmBody SystemInmode MD, Ltd.20198—
+4K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K173285Joule SystemSciton, Inc20185—
+4K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+4K170637sensiFirmEl Global Trade, Ltd.20173—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K162512truSculptCutera, Inc.20165—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K161043Profound SystemSyneron Candela Corporation20160—
+4K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+4K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+4K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+4K153568InMode Plus SystemInmode MD, Ltd.201618—
+4K152611V20 systemViora, Ltd.20164—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K143109XP300BTL Industries, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K142910Legacy BXVenus Concept USA, Inc.201411—
+4K142093V20 SystemViora, Ltd.201432—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+4K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+4K132976AdvatxAdvalight Aps20141—
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+4K111501I-Lipo SystemChromogenex Technologies Limited201215—
+4K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K253750BTL-785NEHBTL Industries, Inc.20260—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243488Vmat ProTermosalud20250—
+5K240311JETT Medical IICompex, Spol, S.R.O.20250—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K242532BTL-785BNF-EBTL Industries, Inc.20241—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K231146AliTightAlic Iotech, LLC20230—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+5K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+5K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—