ACTIFRESH 400 LENS— 510(k) K983637

Substantially Equivalent

Hydron , Ltd.

FDA 510(k) clearance K983637 for ACTIFRESH 400 LENS, Substantially Equivalent on 1999-12-10. Applicant: Hydron , Ltd..

Clearance details

Applicant: Hydron , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-10-16
Decision date: 1999-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farnborough, Hants, 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.