510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182984Substantially Equivalent

MaxiTears Contacts PF

Omnivision AG, Neuhausen Am Rheinfall, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182984 is the FDA 510(k) clearance record for MaxiTears Contacts PF, a class II device, cleared for Omnivision AG on under FDA product code MRC (Products, Contact Lens Care, Rigid Gas Permeable). FDA records list one 510(k) clearance for Omnivision AG. As of , FDA records show no recalls naming K182984.

Clearance record

Decision date
Received
(268 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
Omnivision AG Zentralstr. 100, Neuhausen Am Rheinfall, CH
510(k) summary
Summary PDF
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