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Data / Medical devices / United States / Ray Vision Inc.

Ray Vision Inc.: FDA-registered device maker in Lake Forest, CA, United States, 3 510(k) clearances

Ray Vision Inc. is registered with the FDA (registration 3013436538) in Lake Forest, CA, United States. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 18, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3013436538
Address
17 Spectrum Pointe Dr., Suite 508, Lake Forest, CA, United States, 92630
Owner or operator
Ray Vision Inc (10053843)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
January 17, 2017
Registered through
2026
Brand names listed
Ray Vision Auto Lensmeter, Ray Vision Auto Pupillometer, Ray Vision Chair, Ray Vision Chart Projector, Ray Vision Cross Cylinder, Ray Vision Digital Camera/Imaging System, Ray Vision Exophthalmometer, Ray Vision Hand-held Ophthalmoscopes and more

Devices it lists

DeviceProduct codeClassRoleSource
Aid, Vision Image IntensificationHOT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered, ExemptPUE2Repackager or relabeler, Specification developeraccessdata.fda.gov
Camera, Ophthalmic, General-UsePJZ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Chair, Ophthalmic, Ac-PoweredHME1Repackager or relabeler, Specification developeraccessdata.fda.gov
Chair, Ophthalmic, ManualHMD1Repackager or relabeler, Specification developeraccessdata.fda.gov
Chart, Visual AcuityHOX1Manufactureraccessdata.fda.gov
Clip, Lens, Trial, OphthalmicHPB1Repackager or relabeler, Specification developeraccessdata.fda.gov
ExophthalmometerHLS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Frame, Trial, OphthalmicHPA1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Ophthalmoscope, Ac-PoweredHLI2Repackager or relabeler, Specification developeraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Ophthalmoscopes, Replacement Batteries, Hand-HeldMSG2Repackager or relabeler, Specification developeraccessdata.fda.gov
Perimeter, Ac-PoweredHOO1Repackager or relabeler, Specification developeraccessdata.fda.gov
Perimeter, Automatic, Ac-PoweredHPT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Perimeter, ManualHON1Repackager or relabeler, Specification developeraccessdata.fda.gov
PhotorefractorMMF2Repackager or relabeler, Specification developeraccessdata.fda.gov
Prism, Bar, OphthalmicHKW1Repackager or relabeler, Specification developeraccessdata.fda.gov
Projector, OphthalmicHOS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pupillometer, Ac-PoweredHLG1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pupillometer, ManualHLH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Refractometer, OphthalmicHKO1Repackager or relabeler, Specification developeraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Retinoscope, Ac-PoweredHKL2Repackager or relabeler, Specification developeraccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Set, Lens, Trial, OphthalmicHPC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Simulatan (Including Crossed Cylinder)HOR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Stand, Instrument, Ac-Powered, OphthalmicHMF1Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Repackager or relabeler, Specification developeraccessdata.fda.gov
Table, Instrument, Powered, OphthalmicHRJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Repackager or relabeler, Specification developeraccessdata.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
November 18, 2021K213070MD-320W Ultrasound BiomicroscopeIYOSubstantially EquivalentMEDA Co., Ltd.accessdata.fda.gov
November 17, 2015K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyIYOSubstantially EquivalentMEDA Co., Ltd.accessdata.fda.gov
May 3, 2013K121243ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETERIYOSubstantially EquivalentMEDA Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 18, 2021. 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.