510(k) Report

Devices descending from K933804

803 later devices reach Lectron II Conductive Gel/Cadwell Electrode Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K143554Venus Legacy CXVenus Concept, Ltd.201517—
+5K150035V10 systemViora, Ltd.201531—
+5K143109XP300BTL Industries, Inc.20150—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+5K141904Viora V-TouchViora, Ltd.20140—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+5K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K120510TranscendSyneron Medical, Ltd.201318—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K122579VelashapeSyneron Medical, Ltd.20124—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+5K111026ApolloPollogen, Ltd.201114—
+5K111784Venus Swan SystemVenus Concept, Ltd.20111—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K102461FractoraInvasix, Ltd.201124—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+5K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K083629SmoothshapesEleme Medical, Inc.200927—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K253504Volnewmer™Classys, Inc.20260—
+6K253750BTL-785NEHBTL Industries, Inc.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+6K243488Vmat ProTermosalud20250—
+6K242532BTL-785BNF-EBTL Industries, Inc.20241—
+6K240897CellinewVIOL Co., Ltd.20240—
+6K240313Oligio XWontech Co., Ltd.20241—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K212561MTX-C1Ilooda Co,., Ltd.20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+6K202780SectumNeauvia North America20211—
+6K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192856MT OneM&T S.R.L.20202—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K190678TempSureCynosure, Inc.201914—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K183450EmBody SystemInmode MD, Ltd.20198—
+6K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173285Joule SystemSciton, Inc20185—
+6K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+6K171262TempSureCynosure, Inc.201716—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K170116Thermi Injectable RF ElectrodesThermi20172—
+6K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K162512truSculptCutera, Inc.20165—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—