CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,— 510(k) K150590

Substantially Equivalent

Contamac, Ltd.

FDA 510(k) clearance K150590 for CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,, Substantially Equivalent on 2015-07-10. Applicant: Contamac, Ltd..

Clearance details

Applicant: Contamac, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2015-03-09
Decision date: 2015-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saffron Walden, GB

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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.