510(k) Report

Devices descending from K913758

131 later devices reach KTP/532 and KTP/Yag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc.199820—
+1K974168Coopersurgical Infrared CoagulatorHogan & Hartson1998109—
+2K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+2K060069Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc.2006107—
+2K993967Oratec Spinecath Intradiscal Catheter, Model 920002Oratec Interventions, Inc.19993—
+2K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc.199916—
+2K990855Coopersurgical Infrared Coagulator for EntCooperSurgical, Inc.19990—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K073466Smith & Nephew Intradiscal Catheter SystemSmith & Nephew, Inc.20080—
+3K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+3K063480Stryker RF Intradiscal Adaptor, Model 406-750Stryker Corp.20070—
+3K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc.200414—
+3K013622Nucleotomy Intradiscal CatheterOratec Interventions, Inc.20021—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K192856MT OneM&T S.R.L.20202—
+4K180508Joule SystemSciton, Inc20183—
+4K172413MT ONEM&T S.R.L.20175—
+4K161661Thermi RF AccessoriesThermi20163—
+4K153229SuperbiumBios S.R.L.20162—
+4K152714Quanta ForteQuanta System Spa201513—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K063489Stryker Intradiscal RF GeneratorSynergetics, Inc.20070—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K173285Joule SystemSciton, Inc20185—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K170116Thermi Injectable RF ElectrodesThermi20172—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K142093V20 SystemViora, Ltd.201432—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K234057NirvanaEl.En S.P.A.20240—
+6K230077LaserMENeauvia North America20232—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K22079410PLTentech Co., Ltd.20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K193426Elite iQCynosure, LLC20201—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K152611V20 systemViora, Ltd.20164—
+6K150035V10 systemViora, Ltd.201531—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K180406Ellipse YdunEllipse A/S20180—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—