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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Vision Image Intensification | HOT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Camera, Ophthalmic, General-Use | PJZ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chair, Ophthalmic, Ac-Powered | HME | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chair, Ophthalmic, Manual | HMD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Manufacturer | accessdata.fda.gov |
| Clip, Lens, Trial, Ophthalmic | HPB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Exophthalmometer | HLS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Frame, Trial, Ophthalmic | HPA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ophthalmoscope, Battery-Powered | HLJ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ophthalmoscopes, Replacement Batteries, Hand-Held | MSG | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Perimeter, Ac-Powered | HOO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Perimeter, Manual | HON | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Photorefractor | MMF | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prism, Bar, Ophthalmic | HKW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Projector, Ophthalmic | HOS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pupillometer, Ac-Powered | HLG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pupillometer, Manual | HLH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Refractometer, Ophthalmic | HKO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retinoscope, Ac-Powered | HKL | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retinoscope, Battery-Powered | HKM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Set, Lens, Trial, Ophthalmic | HPC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Simulatan (Including Crossed Cylinder) | HOR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Table, Instrument, Powered, Ophthalmic | HRJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Repackager or relabeler, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 18, 2021 | K213070 | MD-320W Ultrasound Biomicroscope | IYO | Substantially Equivalent | MEDA Co., Ltd. | accessdata.fda.gov |
| November 17, 2015 | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | IYO | Substantially Equivalent | MEDA Co., Ltd. | accessdata.fda.gov |
| May 3, 2013 | K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | IYO | Substantially Equivalent | MEDA Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Ophthalmic, Ac-Powered
- All makers of Chair, Ophthalmic, Manual
- All makers of Perimeter, Manual
- All makers of Set, Lens, Trial, Ophthalmic
- All makers of Frame, Trial, Ophthalmic
- All makers of Ophthalmoscopes, Replacement Batteries, Hand-Held
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.