General Use Information
Use Statement CLEA is a Class I, 510(k)-exempt corneal imaging medical device (21 CFR 886.1350, Product Code HLR — Keratoscope, Battery-Powered), FDA-registered under Establishment Registration No. 3017249918, used by licensed healthcare providers. The CLEA iOS app performs in-office corneal mapping and topographic imaging — capturing high-resolution corneal images and generating keratometry measurements and topographic reports — to help healthcare providers establish a baseline of corneal health and track changes over time. The app is intended for professional use by, or under the direction of, licensed healthcare providers; patients may view resulting reports through the secure CLEA Patient Portal. CLEA is a clinical decision-support tool that assists — and does not replace — the healthcare provider's independent clinical judgment; it does not diagnose conditions or make treatment decisions on its own. Because the device is Class I and 510(k)-exempt, no FDA premarket clearance number applies. Safety Information Clinical decision support only. CLEA assists licensed healthcare providers; it does not replace their clinical judgment. No CLEA result, report, or output is, by itself, a medical diagnosis, treatment recommendation, or clinical determination. The healthcare provider is solely responsible for interpreting data and for all care decisions. Not for emergencies. CLEA is not intended for emergency, high-precision, or time-critical use. If a patient experiences sudden vision loss, eye pain, injury, or any urgent symptom, contact a provider or seek emergency care immediately — do not rely on the app or Portal. Accuracy and availability. Vision Labs works to keep information accurate but does not guarantee that reports or data are error-free. The platform may occasionally be unavailable due to maintenance or updates. If a report looks incorrect or unusual, providers should not base care decisions on data they believe may be wrong. Data and privacy. Patient vision data is collected, stored, and shared as part of care, consistent with applicable privacy laws including HIPAA. Suspected errors, unauthorized access, or privacy concerns should be reported to Vision Labs support promptly. Regulatory. CLEA is a Class I, 510(k)-exempt device (21 CFR 886.1350, Product Code HLR), FDA-registered (Establishment No. 3017249918) and listed. No FDA premarket clearance is required for this device class.
Instructions for Use CLEA (Corneal Light Eye Assessment) — a Class I corneal imaging device (FDA classification: keratoscope, battery-powered), companion iOS application, and secure cloud platform. Regulatory Status Class I, 510(k)-exempt medical device — 21 CFR 886.1350, Product Code HLR (Keratoscope, Battery-Powered), Medical Specialty: Ophthalmic. FDA Establishment Registration No. 3017249918; Owner/Operator No. 10085557. The device is FDA-registered and listed. No FDA premarket clearance — 510(k) — is required for this device class. Product CLEA is a Class I corneal imaging device (FDA classification: keratoscope, battery-powered — 21 CFR 886.1350, Product Code HLR) in a smartphone form factor, with a companion iOS application and a secure cloud platform. It captures images of the cornea and produces keratometry measurements and topographic reports for use by healthcare providers. Intended Use CLEA is intended to capture images of, and to measure and map the curvature and surface of, the cornea (corneal topography / keratometry) to support licensed eye care providers in assessing corneal shape and tracking changes over time. It is intended for use by, or under the direction of, licensed healthcare professionals. Who Uses It The CLEA app is operated in-office by healthcare providers and their staff. Patients may view resulting vision reports through the secure CLEA Patient Portal. How to Use It Sign in to the CLEA app with your provider credentials. Select or register the patient. Position the device as directed and capture the corneal scan following the on-screen guidance. Review the generated keratometry results, topographic map, and PDF report. Reports are stored securely and, where enabled, shared to the Patient Portal and provider records. Important Limitations Clinical decision support, not a diagnostic device. No result or report generated by CLEA is a medical diagnosis, treatment recommendation, or clinical determination on its own. The provider is solely responsible for interpreting results and for all care decisions. Not for emergencies. CLEA is not intended for use in emergency or time-critical situations. In case of sudden vision loss, eye pain, or injury, seek care immediately — do not wait on the app. Support For questions about CLEA, contact Vision Labs inc: support@visionlabsai.com. This document is provided for general awareness and product instruction. It is not a substitute for the full Vision Labs Terms of Use or the advice of a licensed eye care provider.