SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K982774

Substantially Equivalent

Cl-Tinters

FDA 510(k) clearance K982774 for SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 1998-09-02. Applicant: Cl-Tinters.

Clearance details

Applicant: Cl-Tinters
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-08-07
Decision date: 1998-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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.