510(k) Report

Devices descending from K003886

371 later devices reach Palomar Spalight Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160821Tria SapphireTria Beauty, Inc.20160—
+4K160368EVO platformQuanta System Spa201636—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152790Venus Versa SystemVenus Concept, Ltd.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101415TheraclearTheravant Corporation20101—
+4K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+4K090724OR-LightYperion Technology20090—
+4K090399Trios SystemViora, Ltd.20090—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243488Vmat ProTermosalud20250—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K200786Venus EpileveVenus Concept USA, Inc.20200—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K180406Ellipse YdunEllipse A/S20180—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K123889Acleara, TheraclearTheravant Corporation20130—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—