Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens— 510(k) K222954

Substantially Equivalent

Innova Vision, Inc.

FDA 510(k) clearance K222954 for Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens, Substantially Equivalent on 2023-03-13. Applicant: Innova Vision, Inc..

Clearance details

Applicant: Innova Vision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2022-09-27
Decision date: 2023-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.