WETTING SOLUTION FOR HARD CONTACT LENSES— 510(k) K914483

Substantially Equivalent

Optopics Laboratories Corp.

FDA 510(k) clearance K914483 for WETTING SOLUTION FOR HARD CONTACT LENSES, Substantially Equivalent on 1992-02-05. Applicant: Optopics Laboratories Corp..

Clearance details

Applicant: Optopics Laboratories Corp.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 1991-10-08
Decision date: 1992-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairton, NJ, US

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Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

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.