510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994320Substantially Equivalent

Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses

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

K994320 is the FDA 510(k) clearance record for CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES, a class II device, cleared for Cantor & Silver , Ltd. on under FDA product code NCZ (Lens, Contact, For Color Vision Deficiency). FDA records list 4 510(k) clearances for Cantor & Silver , Ltd., from to . As of , FDA records show no recalls naming K994320.

Clearance record

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

Clearances, product code NCZ

Trailing 12 months

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

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