Step 1 · Device identification
OculiRX
Software-only distance visual-acuity screening instrument — measures and reports a per-eye acuity value (logMAR/Snellen) for provider review.
- Trade name
- OculiRX
- Manufacturer
- Centaris Health Inc., Helotes TX
Centaris Health Inc., 15021 Seven L Trail, Helotes, TX 78023 - Device class
- FDA Class I · product code QTO · 21 CFR 886.1150
- Software version
- 0.0.0 (build metadata)
- Indications for use
- OculiRX is indicated for the screening measurement of visual acuity (monocular and binocular) in adults aged 22–40, self-administered under the supervision of a licensed eye-care professional who reviews every result, for eyeglass or contact-lens prescription renewal or monitoring between in-office exams. It reports a measured per-eye acuity value (logMAR/Snellen) as a screening-grade record only.
- Prescription status
- Prescription use only (Rx). Federal law restricts this device to use by or on the order of a licensed eye-care provider. Access is gated by a provider-issued credential.
OculiRX explicitly:
- does not diagnose any condition
- does not replace a comprehensive eye exam
- does not render a clinical decision
- does not measure refractive error, color vision, depth perception, contrast sensitivity, or visual field
- does not generate eyeglass or contact-lens prescriptions