510(k) Report

Devices descending from K003183

833 later devices reach Thermage Thermacool II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+6K152731XP1100 RFBTL Industries, Inc.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—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250165PastelleWontech Co., Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K250200InbellaBody SystemInbella Medical, Inc.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K241535Vybe RF IIShenB Co., Ltd.20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240999Legend X Applicator VOPollogen, Ltd.20241—
+7K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K230837PlazMagikAgnes Medical Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232223PlaDuo SystemShenB Co., Ltd.20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K203013AGNESAgnes Medical Co., Ltd.20224—
+7K221407truSculpt iDCutera, Inc.20222—
+7K212472AgeJetTriworks Group Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K213814Viveve 2.0 SystemViveve, Inc.20220—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+7K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—