510(k) Report

Devices descending from K030186

680 later devices reach Polris LV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+6K171702Exciplex308nmClarteis20175—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K171262TempSureCynosure, Inc.201716—
+6K172004truSculptCutera, Inc.20173—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161661Thermi RF AccessoriesThermi20163—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K152731XP1100 RFBTL Industries, Inc.20160—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K160368EVO platformQuanta System Spa201636—
+6K151793InMode RF SystemInmode MD, Ltd.20161—
+6K152012EVO platformQuanta System Spa201537—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131839DC 7Dc International, LLC20130—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K111689StlaseDental Photonics, Inc.201222—
+7K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K250200InbellaBody SystemInbella Medical, Inc.20250—
+7K243929Oligio XWontech Co., Ltd.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—