510(k) Report

Devices descending from K013034

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+10K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+10K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+10K243737Inbella RF SystemInbella Medical, Inc.20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233224Epilaser ProEpilady 2000, LLC20240—
+10K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K220853PicoWay Laser SystemCandela Corporation20221—