510(k) Report

Devices descending from K933362

1,220 later devices reach Sharplan CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+10K201406PicowonWontech Co., Ltd.20200—
+10K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—
+10K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+10K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+10K200241TempSure SystemCynosure, LLC202013—
+10K192430Epic 980Biolase, Inc.20195—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+10K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+10K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+10K190443MMSphereGalactic Beauty, LLC201942—
+10K183156V-LaserWontech Co., Ltd.20193—
+10K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+10K181518Sebacia MicroparticlesSebacia, Inc.20180—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+10K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+10K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+10K173199PicoSure WorkstationCynosure, Inc.20189—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+10K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+10K170984LG Beauty Led MaskLg Electronics201793—
+10K162755PicocareWontech Co., Ltd.20179—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+10K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+10K170500SIROLaser Advance+Dentsply Sirona201721—
+10K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+10K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+10K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K161185LUCERNA Dental LaserViax Dental Lab20160—
+10K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+10K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+10K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+10K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+10K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+10K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+10K160691Acne Light Therapy WandZuko, Inc.201650—
+10K152856Helios IIILaseroptek Co., Ltd.20165—
+10K160480PicoSure WorkstationCynosure, Inc.201620—
+10K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+10K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+10K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+10K150326PicoWay Laser SystemCandela Corporation201568—
+10K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+10K143105Picosure WorkstationCynosure, Inc.201549—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K142372Pico Way Laser SystemCandela Corpation201470—
+10K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+10K140719Picosure WorkstationCynosure, Inc.201450—
+10K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+10K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+10K131839DC 7Dc International, LLC20130—
+10K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+10K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+10K130465EPIC 10SBiolase Technology, Inc.20130—
+10K111689StlaseDental Photonics, Inc.201222—
+11K252723Dynamis Pro FamilyFotona D.O.O.20260—
+11K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+11K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+11K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+11K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+11K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+11K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+11K253342PICO-KSpeclipse, Inc.20251—
+11K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+11K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+11K251730LIA Console (542-7)Leadoptik, Inc.20250—
+11K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+11K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+11K253344Bellus-QSpeclipse, Inc.20250—
+11K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+11K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+11K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—