HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%— 510(k) K952261

Substantially Equivalent

Pilkington Barnes-Hind, Ltd.

FDA 510(k) clearance K952261 for HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%, Substantially Equivalent on 1995-07-05. Applicant: Pilkington Barnes-Hind, Ltd..

Clearance details

Applicant: Pilkington Barnes-Hind, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1995-05-15
Decision date: 1995-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hedge End, Southampton, 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.