510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984219Substantially Equivalent

Colormax Color Vision Enhancement Lenses

Color Vision Technologies, Inc., Rowland Heights CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984219 is the FDA 510(k) clearance record for COLORMAX COLOR VISION ENHANCEMENT LENSES, a class I device, cleared for Color Vision Technologies, Inc. on under FDA product code NAI (Lens, Prescription, Color Deficiency). FDA records list one 510(k) clearance for Color Vision Technologies, Inc. As of , FDA records show no recalls naming K984219.

Clearance record

Decision date
Received
(358 days to decision)
Product code
NAI Lens, Prescription, Color Deficiency
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Applicant
Color Vision Technologies, Inc. 19726 Colima Rd., Rowland Heights CA
510(k) summary
Summary
Third party review
No

Clearances, product code NAI

Trailing 12 months

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

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