510(k) Report

Devices descending from K012398

714 later devices reach Diomed 15 Diode Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152714Quanta ForteQuanta System Spa201513—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K133405MinnieElettronica Valseriana Srl20140—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131839DC 7Dc International, LLC20130—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K132431Thermage CPT SystemSolta Medical, Inc.2013171
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+5K111689StlaseDental Photonics, Inc.201222—
+5K111026ApolloPollogen, Ltd.201114—
+5K111784Venus Swan SystemVenus Concept, Ltd.20111—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+5K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K193201BTL-785FBtl20208—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191086ExciplexClarteis20194—
+6K192430Epic 980Biolase, Inc.20195—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—