BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K013377

Substantially Equivalent

Ocular Sciences Puerto Rico, Inc.

FDA 510(k) clearance K013377 for BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2001-12-20. Applicant: Ocular Sciences Puerto Rico, Inc..

Clearance details

Applicant: Ocular Sciences Puerto Rico, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-10-12
Decision date: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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.