510(k) Report

Devices descending from K020339

695 later devices reach Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+4K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+4K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251730LIA Console (542-7)Leadoptik, Inc.20250—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K202172StarWalkerFotona D.O.O.20203—
+5K193201BTL-785FBtl20208—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191086ExciplexClarteis20194—
+5K192430Epic 980Biolase, Inc.20195—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+5K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K163128Epic ProBiolase, Inc.201716—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142910Legacy BXVenus Concept USA, Inc.201411—