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Data / Medical devices / United States / International Medical Lasers, Inc.

International Medical Lasers, Inc.: FDA-registered device maker in Tualatin, OR, United States, 19 510(k) clearances

International Medical Lasers, Inc. is registered with the FDA (registration 3009453258) in Tualatin, OR, United States. It lists 5 device types. The FDA files 19 510(k) clearances under its listings, the newest dated June 10, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch International Medical Lasers, Inc.
FDA registration number
3009453258
Address
18057 Teton Ave, Tualatin, OR, United States, 97062
Owner or operator
International Medical Lasers, Inc./Mooney (10039842)
Roles
Complaint file establishment
First device listed
August 5, 2020
Registered through
2026
Brand names listed
BubbleView/S-13, CoralView, Cyber Blade, Cyber Ho 100, Cyber Ho 150, Cyber Ho 60, Cyber Tm Family, Deka Smartxide Trio and more

Devices it lists

DeviceProduct codeClassRoleSource
Cystoscope And Accessories, Flexible/RigidFAJ2Complaint file establishmentaccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Complaint file establishmentaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Complaint file establishmentaccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Complaint file establishmentaccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 10, 2024K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)FAJSubstantially EquivalentMacroLux Medical Technology Co., Ltd.accessdata.fda.gov
January 11, 2024K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)FGBSubstantially EquivalentMacroLux Medical Technology Co., Ltd.accessdata.fda.gov
June 2, 2023K231309SCAR 3GEXSubstantially EquivalentEl.En Electroinc Engineering Spaaccessdata.fda.gov
September 26, 2022K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)FAJSubstantially EquivalentZhuhai Pusen Medical Technology Co., Ltd.accessdata.fda.gov
March 16, 2022K220426Fiber Dust PROGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
August 25, 2021K211362SCAR 3GEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
March 11, 2021K210142Fiber DustGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 15, 2020K202041Opera EvoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
July 31, 2020K192499Cyber BladeGCJSubstantially EquivalentSIDAM S.r.l.accessdata.fda.gov
June 30, 2020K201455Litho 150, Cyber Ho 150GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
February 25, 2020K200234Surgical laser fibersGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
February 21, 2020K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
December 20, 2019K192990Litho EvoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
March 29, 2019K190648Pusen Eview Medical Video Endoscope Image ProcessorFETSubstantially EquivalentZhuhai Pusen Medical Technology Co., Ltd.accessdata.fda.gov
October 2, 2018K181867Deka Smartxide2 TrioGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
August 31, 2017K172098Medical Video Endoscope SystemFGBSubstantially EquivalentZhuhai Pusen Medical Technology Co., Ltd.accessdata.fda.gov
December 1, 2016K163009LithoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
August 7, 2014K141403LITHO DK30GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
July 3, 2013K131081CYBER TM FAMILYGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov

Compare with other makers

Updated June 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.