510(k) Report

Devices descending from K070298

64 later devices reach Modification to Palomar Luxir Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+1K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+2K233473Deka LotusEl.En S.P.A.20241—
+2K192856MT OneM&T S.R.L.20202—
+2K173285Joule SystemSciton, Inc20185—
+2K153229SuperbiumBios S.R.L.20162—
+2K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+2K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+2K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+2K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K250281Deka LotusEl.En S.P.A.20250—
+3K241270BTL-754BTL Industries, Inc.20251—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K230077LaserMENeauvia North America20232—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K193426Elite iQCynosure, LLC20201—
+3K180508Joule SystemSciton, Inc20183—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+3K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K200616E>EyeCE-Swin20200—
+4K200786Venus EpileveVenus Concept USA, Inc.20200—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K180406Ellipse YdunEllipse A/S20180—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K22079410PLTentech Co., Ltd.20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K242349FoLixLumenis Be, Ltd.20240—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—