510(k) Report

Devices descending from K003183

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233766Geneo X ElitePollogen, Ltd.20240—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+9K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K232236EchoQuanta System Spa20230—
+9K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+9K223292TempSure SystemCynosure, LLC20220—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K213344BTL-899ABTL Industries, Inc.20222—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K202172StarWalkerFotona D.O.O.20203—
+9K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K193426Elite iQCynosure, LLC20201—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K192430Epic 980Biolase, Inc.20195—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+9K183156V-LaserWontech Co., Ltd.20193—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+9K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K171702Exciplex308nmClarteis20175—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K171111SculpsureCynosure, Inc.201710—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K160368EVO platformQuanta System Spa201636—
+9K152012EVO platformQuanta System Spa201537—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K124064Young AgainEspansione Marketing S.P.A20131—
+9K131839DC 7Dc International, LLC20130—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K111689StlaseDental Photonics, Inc.201222—
+10K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+10K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+10K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K253342PICO-KSpeclipse, Inc.20251—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—