UniVit HE, UniVit UHS— 510(k) K212763

Substantially Equivalent

Visioncare Devices, LLC

FDA 510(k) clearance K212763 for UniVit HE, UniVit UHS, Substantially Equivalent on 2022-08-10. Applicant: Visioncare Devices, LLC.

Clearance details

Applicant: Visioncare Devices, LLC
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 2021-08-31
Decision date: 2022-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anderson, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.