510(k) Report

Devices descending from K955758

701 later devices reach Indigo Medical Model Idl 830E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K152714Quanta ForteQuanta System Spa201513—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131839DC 7Dc International, LLC20130—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+6K111026ApolloPollogen, Ltd.201114—
+6K111784Venus Swan SystemVenus Concept, Ltd.20111—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+6K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K250165PastelleWontech Co., Ltd.20250—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—