510(k) Report

Devices descending from K013034

800 later devices reach Modification to: Thermacool Iia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K250200InbellaBody SystemInbella Medical, Inc.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K22079410PLTentech Co., Ltd.20220—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K212561MTX-C1Ilooda Co,., Ltd.20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K221407truSculpt iDCutera, Inc.20222—
+6K210084SilkroHironic Co., Ltd.20223—
+6K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202780SectumNeauvia North America20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+6K202199BTL-899STBtl20216—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200616E>EyeCE-Swin20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K190678TempSureCynosure, Inc.201914—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K183450EmBody SystemInmode MD, Ltd.20198—
+6K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K180508Joule SystemSciton, Inc20183—
+6K173285Joule SystemSciton, Inc20185—
+6K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+6K172413MT ONEM&T S.R.L.20175—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K170116Thermi Injectable RF ElectrodesThermi20172—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152611V20 systemViora, Ltd.20164—
+6K152714Quanta ForteQuanta System Spa201513—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K142093V20 SystemViora, Ltd.201432—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K132754Neogen PSR SystemEnergist, Ltd.20132—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+6K111501I-Lipo SystemChromogenex Technologies Limited201215—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—