510(k) Report

Devices descending from K800617

1,325 later devices reach Hyfrecator, #733 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+9K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+9K201406PicowonWontech Co., Ltd.20200—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+9K200241TempSure SystemCynosure, LLC202013—
+9K192430Epic 980Biolase, Inc.20195—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K190443MMSphereGalactic Beauty, LLC201942—
+9K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+9K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+9K173199PicoSure WorkstationCynosure, Inc.20189—
+9K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K170984LG Beauty Led MaskLg Electronics201793—
+9K162755PicocareWontech Co., Ltd.20179—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+9K163128Epic ProBiolase, Inc.201716—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+9K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+9K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+9K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+9K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+9K160691Acne Light Therapy WandZuko, Inc.201650—
+9K152856Helios IIILaseroptek Co., Ltd.20165—
+9K160480PicoSure WorkstationCynosure, Inc.201620—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+9K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K150724SculpSureCynosure, Inc.201521—
+9K150230SculpSureCynosure, Inc.201521—
+9K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+9K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+9K150326PicoWay Laser SystemCandela Corporation201568—
+9K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+9K143105Picosure WorkstationCynosure, Inc.201549—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K142372Pico Way Laser SystemCandela Corpation201470—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K140719Picosure WorkstationCynosure, Inc.201450—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+9K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+9K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+9K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+9K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+10K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+10K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+10K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253712LED 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—
+10K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+10K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+10K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+10K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+10K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+10K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+10K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—