510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051684Substantially Equivalent

Eyeport Vision Training System

Exercise Your Eyes, Inc., Kula HI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051684 is the FDA 510(k) clearance record for EYEPORT VISION TRAINING SYSTEM, a class I device, cleared for Exercise Your Eyes, Inc. on under FDA product code NXR (Fixation, Vision Training, Binocular). FDA's definition for product code NXR reads: "To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation. To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag". FDA records list one 510(k) clearance for Exercise Your Eyes, Inc. As of , FDA records show no recalls naming K051684.

Clearance record

Decision date
Received
(267 days to decision)
Product code
NXR Fixation, Vision Training, Binocular
Regulation
21 CFR 886.1290
Device class
Class I
Review panel
Ophthalmic
Applicant
Exercise Your Eyes, Inc. 133 Ka Dr., Kula HI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXR

Trailing 12 months

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

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