BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS— 510(k) K984046

Substantially Equivalent

Ocular Sciences Puerto Rico, Inc.

FDA 510(k) clearance K984046 for BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS, Substantially Equivalent on 1999-01-21. Applicant: Ocular Sciences Puerto Rico, Inc..

Clearance details

Applicant: Ocular Sciences Puerto Rico, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-11-12
Decision date: 1999-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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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.