ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES— 510(k) K042242

Substantially Equivalent

Alden Optical Labs., Inc.

FDA 510(k) clearance K042242 for ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES, Substantially Equivalent on 2004-09-15. Applicant: Alden Optical Labs., Inc..

Clearance details

Applicant: Alden Optical Labs., Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2004-08-19
Decision date: 2004-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Alden, NY, US

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.