510(k) Report

Devices descending from K021402

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K142093V20 SystemViora, Ltd.201432—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+5K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+5K132976AdvatxAdvalight Aps20141—
+5K131758Surgen UPollogen, Ltd.20135—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K111501I-Lipo SystemChromogenex Technologies Limited201215—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K090094Zeltiq SystemZeltiq Aesthetics200932—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+6K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+6K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K231948MediyagMedicreations, LLC20240—
+6K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+6K231146AliTightAlic Iotech, LLC20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K22079410PLTentech Co., Ltd.20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+6K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200616E>EyeCE-Swin20200—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K200241TempSure SystemCynosure, LLC202013—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192224BTL-899Btl20198—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+6K180508Joule SystemSciton, Inc20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+6K172413MT ONEM&T S.R.L.20175—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K172004truSculptCutera, Inc.20173—
+6K170325Secret RFIlooda Co,., Ltd.201710—