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
K143351Substantially Equivalent

iCase Contact Lens Case

Novabay Pharmaceuticals, Inc, Emeryville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143351 is the FDA 510(k) clearance record for iCase Contact Lens Case, a class II device, cleared for Novabay Pharmaceuticals, Inc. on under FDA product code LRX (Case, Contact Lens). FDA records list 5 510(k) clearances for Novabay Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K143351.

Clearance record

Decision date
Received
(156 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Novabay Pharmaceuticals, Inc. 5980 Horton St. Suite 550, Emeryville CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRX

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