510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K803256Substantially Equivalent

Eyetech-Vision Screening System

Eyedex, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803256 is the FDA 510(k) clearance record for EYETECH-VISION SCREENING SYSTEM, a class I device, cleared for Eyedex on under FDA product code HOX (Chart, Visual Acuity). FDA records list one 510(k) clearance for Eyedex. As of , FDA records show no recalls naming K803256.

Clearance record

Decision date
Received
(71 days to decision)
Product code
HOX Chart, Visual Acuity
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Applicant
Eyedex 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HOX

Trailing 12 months

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

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