510(k) Report

Devices descending from K040081

415 later devices reach Palomar Luxv Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+4K250809Stellar M22Lumenis Be, Ltd.20250—
+4K250281Deka LotusEl.En S.P.A.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K241270BTL-754BTL Industries, Inc.20251—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K231948MediyagMedicreations, LLC20240—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230077LaserMENeauvia North America20232—
+4K222790F65 Laser SystemLumenis Be, Ltd.20233—
+4K222221Deka HelixEl.En Electronic Engineering Spa20231—
+4K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193426Elite iQCynosure, LLC20201—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160368EVO platformQuanta System Spa201636—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152790Venus Versa SystemVenus Concept, Ltd.20160—
+4K142093V20 SystemViora, Ltd.201432—
+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—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123889Acleara, TheraclearTheravant Corporation20130—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K090724OR-LightYperion Technology20090—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.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—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+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—
+5K242349FoLixLumenis Be, Ltd.20240—
+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—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200786Venus EpileveVenus Concept USA, Inc.20200—