Eagle device— 510(k) K230722

Substantially Equivalent

Belkin Vision, Ltd.

FDA 510(k) clearance K230722 for Eagle device, Substantially Equivalent on 2023-12-08. Applicant: Belkin Vision, Ltd..

Clearance details

Applicant: Belkin Vision, Ltd.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2023-03-16
Decision date: 2023-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yavne, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.