510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072643Substantially Equivalent

Crystaleye Spectrophotometer/crystaleye Basic Set, Model Ce100-Dc/us

Olympus Corp., Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072643 is the FDA 510(k) clearance record for CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US, a class II device, cleared for Olympus Corporation on under FDA product code KZN (Scanner, Color). FDA records list 149 510(k) clearances for Olympus Corporation, from to . As of , FDA records show no recalls naming K072643.

Clearance record

Decision date
Received
(59 days to decision)
Product code
KZN Scanner, Color
Regulation
21 CFR 872.3661
Device class
Class II
Review panel
Dental
Applicant
Olympus Corporation 4-2-1 Yushima, Tokyo, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZN

Trailing 12 months

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

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