510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012298Substantially Equivalent

The Intuitive Colorimeter

Cerium Optical Technologies, Inc., Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012298 is the FDA 510(k) clearance record for THE INTUITIVE COLORIMETER, a class I device, cleared for Cerium Optical Technologies, Inc. on under FDA product code NFD (Selector, Color, Spectacle, Lens, Tint). FDA records list one 510(k) clearance for Cerium Optical Technologies, Inc. As of , FDA records show no recalls naming K012298.

Clearance record

Decision date
Received
(68 days to decision)
Product code
NFD Selector, Color, Spectacle, Lens, Tint
Regulation
21 CFR 886.1160
Device class
Class I
Review panel
Ophthalmic
Applicant
Cerium Optical Technologies, Inc. 36 Bradford Rd., Natick MA
510(k) summary
Summary
Third party review
No

Clearances, product code NFD

Trailing 12 months

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

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