510(k) Report

Devices descending from K033942

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250165PastelleWontech Co., Ltd.20250—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+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—
+6K250200InbellaBody SystemInbella Medical, Inc.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221407truSculpt iDCutera, Inc.20222—
+6K210084SilkroHironic Co., Ltd.20223—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+6K202199BTL-899STBtl20216—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K190678TempSureCynosure, Inc.201914—
+6K182365TempSure SystemCynosure, Inc.201815—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K170116Thermi Injectable RF ElectrodesThermi20172—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K242349FoLixLumenis Be, Ltd.20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240999Legend X Applicator VOPollogen, Ltd.20241—
+7K230837PlazMagikAgnes Medical Co., Ltd.20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232223PlaDuo SystemShenB Co., Ltd.20230—