510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001235Substantially Equivalent

Opti-Free Supraclens Daily Potein Remover / Rgp Multi-Purpose Disinfecting Solution Id 100136

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

K001235 is the FDA 510(k) clearance record for OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136, a class II device, cleared for Alcon Universal, Ltd. on under FDA product code MRC (Products, Contact Lens Care, Rigid Gas Permeable). FDA records list 5 510(k) clearances for Alcon Universal, Ltd., from to . As of , FDA records show no recalls naming K001235.

Clearance record

Decision date
Received
(77 days to decision)
Product code
MRC Products, Contact Lens Care, Rigid Gas Permeable
Regulation
21 CFR 886.5918
Device class
Class II
Review panel
Ophthalmic
Applicant
Alcon Universal, Ltd. 6201 S. Fwy., Fort Worth TX
510(k) summary
Summary
Third party review
No

Clearances, product code MRC

Trailing 12 months

FDA records hold no clearances under product code MRC in the trailing twelve months.

FDA records show no clearances under product code MRC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260