510(k) Report

Devices descending from K971711

978 later devices reach Somnus Model 215 Electrosurgical Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K181659Avologi ENEOPremier North America, Inc.20184—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+7K180508Joule SystemSciton, Inc20183—
+7K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+7K180320dpl IIa PanelLed Technologies, Inc.201814—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172111Vevazz LEDVevazz, LLC20170—
+7K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+7K171702Exciplex308nmClarteis20175—
+7K172413MT ONEM&T S.R.L.20175—
+7K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K152714Quanta ForteQuanta System Spa201513—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K133405MinnieElettronica Valseriana Srl20140—
+7K133837Viora V-TotalViora, Ltd.201433—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K131839DC 7Dc International, LLC20130—
+7K130459Tria Fan SystemTria Beauty, Inc.20131—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K132431Thermage CPT SystemSolta Medical, Inc.2013171
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+7K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+7K111689StlaseDental Photonics, Inc.201222—
+7K111026ApolloPollogen, Ltd.201114—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K111784Venus Swan SystemVenus Concept, Ltd.20111—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+7K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+7K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+7K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+7K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+7K101321Ematrix CO2Syneron Medical, Ltd.20102—
+7K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+7K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+7K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+7K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+7K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+7K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261473ChromixTermosalud S.L.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—