OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)— 510(k) K981252

Substantially Equivalent

Alden Optical Labs., Inc.

FDA 510(k) clearance K981252 for OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR), Substantially Equivalent on 1998-06-23. Applicant: Alden Optical Labs., Inc..

Clearance details

Applicant: Alden Optical Labs., Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-04-06
Decision date: 1998-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

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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.