BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS— 510(k) K020389

Substantially Equivalent

Ocular Sciences

FDA 510(k) clearance K020389 for BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS, Substantially Equivalent on 2002-06-04. Applicant: Ocular Sciences. Device class: 2.

Clearance details

Applicant
Ocular Sciences
Product code
Code MVN
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockville, MD, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MVN

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Adverse events under product code MVN

product code MVN
Injury
149
Total
149

Source: openFDA MAUDE database, through . 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.