510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202036Substantially Equivalent

Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal

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

K202036 is the FDA 510(k) clearance record for Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal, a class II device, cleared for Alcon Laboratories, Inc. on under FDA product code MVN (Lens, Contact, (Disposable)). FDA records list 152 510(k) clearances for Alcon Laboratories, Inc., from to . As of , FDA records show no recalls naming K202036.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MVN Lens, Contact, (Disposable)
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Alcon Laboratories, Inc. 6201 S. Fwy., Fort Worth TX
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