510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K020389Substantially Equivalent

Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens

Ocular Sciences, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020389 is the FDA 510(k) clearance record for BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS, a class II device, cleared for Ocular Sciences on under FDA product code MVN (Lens, Contact, (Disposable)). FDA records list 2 510(k) clearances for Ocular Sciences, from to . As of , FDA records show no recalls naming K020389.

Clearance record

Decision date
Received
(119 days to decision)
Product code
MVN Lens, Contact, (Disposable)
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Ocular Sciences 12300 Twinbrook Pkwy. Suite 230, Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MVN

Trailing 12 months
1 clearance under product code MVN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260