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

Fixation, Vision Training, Binocular

21 CFR 886.1290 / Ophthalmic
FDA source (opens on fda.gov)

NXR is the FDA product code for Fixation, Vision Training, Binocular, a class I device type, regulated under 21 CFR 886.1290. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NXR
Device name
Fixation, Vision Training, Binocular
FDA definition
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.
Regulation
21 CFR 886.1290
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NXR

By decision year
1 clearance under product code NXR with a decision year between 2006 and 2006, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NXR by decision year
YearClearances
20061

Applicants with the most clearances

Product code NXR
Applicants holding the most 510(k) clearances under product code NXR
ApplicantClearances
Exercise Your Eyes, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order