METRO FOCAL ASPHERIC (POLYMACON)— 510(k) K961606

Substantially Equivalent

Metro Optics of Austin, Inc.

FDA 510(k) clearance K961606 for METRO FOCAL ASPHERIC (POLYMACON), Substantially Equivalent on 1996-11-20. Applicant: Metro Optics of Austin, Inc..

Clearance details

Applicant: Metro Optics of Austin, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1996-04-25
Decision date: 1996-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosewell, GA, 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.