510(k) Report

Devices descending from K053365

203 later devices reach Modification to Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+5K210084SilkroHironic Co., Ltd.20223—
+5K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+5K201685PotenzaJeisys Medical, Inc.20219—
+5K201735PlaDuo SystemShenB Co., Ltd.20203—
+5K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192224BTL-899Btl20198—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K171262TempSureCynosure, Inc.201716—
+5K172004truSculptCutera, Inc.20173—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K161661Thermi RF AccessoriesThermi20163—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K102461FractoraInvasix, Ltd.201124—
+6K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K250200InbellaBody SystemInbella Medical, Inc.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K231216PotenzaJeisys Medical, Inc.20244—
+6K231287PotenzaJeisys Medical, Inc.20241—
+6K233123SilkroHironic Co., Ltd.20241—
+6K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K240999Legend X Applicator VOPollogen, Ltd.20241—
+6K230837PlazMagikAgnes Medical Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233147PiXel8-RFRohrer Aesthetics20230—
+6K232223PlaDuo SystemShenB Co., Ltd.20230—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+6K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K221407truSculpt iDCutera, Inc.20222—
+6K212472AgeJetTriworks Group Srl20220—
+6K211000AcutronIlooda Co,., Ltd.20220—
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202199BTL-899STBtl20216—
+6K190678TempSureCynosure, Inc.201914—
+6K182365TempSure SystemCynosure, Inc.201815—
+6K170116Thermi Injectable RF ElectrodesThermi20172—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K131758Surgen UPollogen, Ltd.20135—
+7K254185Potenza PrimeJeisys Medical Incorporated20260—
+7K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+7K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+7K253803MILAN SystemLumenis Be, Ltd.20260—
+7K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+7K251254Ignite RF SystemInMode, Ltd.20260—
+7K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+7K252367InbellaMulti SystemInbella Medical, Inc.20250—
+7K251334New Doublo 2.0Hironic Co., Ltd.20250—
+7K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K233766Geneo X ElitePollogen, Ltd.20240—
+7K233642InMode RF SystemInMode, Ltd.20244—
+7K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+7K223110truSculpt iDCutera, Inc.20221—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K211107BTL-899 FPBTL Industries, Inc.20213—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K200241TempSure SystemCynosure, LLC202013—
+8K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+8K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+8K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+8K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+8K240780InMode RF SystemInMode, Ltd.20243—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K212891TempSure SystemCynosure, LLC20221—
+8K213344BTL-899ABTL Industries, Inc.20222—
+8K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—