510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212631Substantially Equivalent

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

Contamac Ltd., Saffron Walden, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212631 is the FDA 510(k) clearance record for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses, a class II device, cleared for Contamac, Ltd. on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list 18 510(k) clearances for Contamac, Ltd., from to . As of , FDA records show no recalls naming K212631.

Clearance record

Decision date
Received
(210 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Contamac, Ltd. Carlton House, Saffron Walden, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQD

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