CONTACT LENS WITH COLOR ADDITIVE— 510(k) K962911

Substantially Equivalent

Cal Bionics

FDA 510(k) clearance K962911 for CONTACT LENS WITH COLOR ADDITIVE, Substantially Equivalent on 1996-11-29. Applicant: Cal Bionics.

Clearance details

Applicant: Cal Bionics
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1996-07-24
Decision date: 1996-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Novato, CA, 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.