510(k) Report

Devices descending from K060069

107 later devices reach Palomar Luxir Fractional Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+1K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+2K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+2K192856MT OneM&T S.R.L.20202—
+2K180508Joule SystemSciton, Inc20183—
+2K172413MT ONEM&T S.R.L.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K152714Quanta ForteQuanta System Spa201513—
+2K133837Viora V-TotalViora, Ltd.201433—
+2K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+2K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+3K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233473Deka LotusEl.En S.P.A.20241—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K210847UltraClear Fractional Laser SystemFa International, LP20210—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191942MT One DiamondM&T S.R.L.20191—
+3K173285Joule SystemSciton, Inc20185—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+3K142093V20 SystemViora, Ltd.201432—
+3K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+3K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+3K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K250281Deka LotusEl.En S.P.A.20250—
+4K241270BTL-754BTL Industries, Inc.20251—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K230077LaserMENeauvia North America20232—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200736Stardust MedI.T.S. Group S.R.L.20200—
+4K200616E>EyeCE-Swin20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K193426Elite iQCynosure, LLC20201—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K152611V20 systemViora, Ltd.20164—
+4K150035V10 systemViora, Ltd.201531—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K200786Venus EpileveVenus Concept USA, Inc.20200—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K180406Ellipse YdunEllipse A/S20180—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K242349FoLixLumenis Be, Ltd.20240—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—