510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983291Substantially Equivalent

Solo-Care Brand Multi-Purpose Solution

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

K983291 is the FDA 510(k) clearance record for SOLO-CARE BRAND MULTI-PURPOSE SOLUTION, a class II device, cleared for Ciba Vision Corporation on under FDA product code MRC (Products, Contact Lens Care, Rigid Gas Permeable). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show no recalls naming K983291.

Clearance record

Decision date
Received
(65 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
Ciba Vision Corporation 11460 Johns Creek Pkwy., Duluth GA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260