510(k) Report

Devices descending from K033176

522 later devices reach Tristar Aesthetic Workstation Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152012EVO platformQuanta System Spa201537—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K140120EPIC 10Biolase, Inc.20141—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K210084SilkroHironic Co., Ltd.20223—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K201773PicohiHironic Co., Ltd.20215—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K131839DC 7Dc International, LLC20130—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—