510(k) Report

Devices descending from K041086

365 later devices reach Palomar Starlux Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K152714Quanta ForteQuanta System Spa201513—
+3K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+3K113588Spectra Laser SystemLutronic Corporation201282—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101415TheraclearTheravant Corporation20101—
+3K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+3K090724OR-LightYperion Technology20090—
+3K090399Trios SystemViora, Ltd.20090—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243488Vmat ProTermosalud20250—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+4K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K221865BTL-094BTL Industries, Inc.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K210166Omnispec ED1000Medispec, Ltd.20230—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K200786Venus EpileveVenus Concept USA, Inc.20200—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K180406Ellipse YdunEllipse A/S20180—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K171648BM.IrisBluecore Co., Ltd.20172—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K140837Lucid LYBio-Med USA, Inc.20140—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K123889Acleara, TheraclearTheravant Corporation20130—
+4K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K251094Alma VeilWontech Co., Ltd.20250—