510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021143Substantially Equivalent

Opti-Free Express Multi-Purpose Disinfecting Solution

Alcon Universal, Ltd., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021143 is the FDA 510(k) clearance record for OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION, a class II device, cleared for Alcon Universal, Ltd. on under FDA product code LPN (Accessories, Soft Lens Products). FDA records list 5 510(k) clearances for Alcon Universal, Ltd., from to . As of , FDA records show one recall naming K021143.

Clearance record

Decision date
Received
(121 days to decision)
Product code
LPN Accessories, Soft Lens Products
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Alcon Universal, Ltd. 6201 S. Fwy., Fort Worth TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPN

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