NOVAKONE SPHERICAL AND TORIC LENSES— 510(k) K102557

Substantially Equivalent

Alden Optical Labs., Inc.

FDA 510(k) clearance K102557 for NOVAKONE SPHERICAL AND TORIC LENSES, Substantially Equivalent on 2011-04-26. Applicant: Alden Optical Labs., Inc..

Clearance details

Applicant: Alden Optical Labs., Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2010-09-07
Decision date: 2011-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alden, NY, 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.