510(k) Report

Devices descending from K014040

739 later devices reach Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+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—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+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—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K213428EdgeProBiolase, Inc.20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K191086ExciplexClarteis20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183566CLARITY II Laser SystemLutronic Corporation201911
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K180406Ellipse YdunEllipse A/S20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—