510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010636Substantially Equivalent

Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact

Alcon Laboratories, Duluth GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010636 is the FDA 510(k) clearance record for FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT, a class II device, cleared for Ciba Vision Corporation on under FDA product code MVN (Lens, Contact, (Disposable)). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show no recalls naming K010636.

Clearance record

Decision date
Received
(18 days to decision)
Product code
MVN Lens, Contact, (Disposable)
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Ciba Vision Corporation 11460 Johns Creek Pkwy., Duluth GA
510(k) summary
Summary
Third party review
No

Clearances, product code MVN

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