510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012132Substantially Equivalent

Chromagen V3.0 Reading Aid Soft Contact Lens

Cantor & Nissel, Ltd., Grand Junction CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012132 is the FDA 510(k) clearance record for CHROMAGEN V3.0 READING AID SOFT CONTACT LENS, a class II device, cleared for Cantor & Nissel , Ltd. on under FDA product code NIC (Lens, Contact, For Reading Discomfort). FDA's definition for product code NIC reads: "This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to...". FDA records list 3 510(k) clearances for Cantor & Nissel , Ltd., from to . As of , FDA records show no recalls naming K012132.

Clearance record

Decision date
Received
(304 days to decision)
Product code
NIC Lens, Contact, For Reading Discomfort
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Cantor & Nissel , Ltd. 623 Glacier Dr., Grand Junction CO
510(k) summary
Summary
Third party review
No

Clearances, product code NIC

Trailing 12 months

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

FDA records show no clearances under product code NIC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NIC, 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