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

Digital Therapy Device For Convergence Insufficiency

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

SBN is the FDA product code for Digital Therapy Device For Convergence Insufficiency, a class I device type, regulated under 21 CFR 886.1290. FDA's definition for this code reads: "A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SBN
Device name
Digital Therapy Device For Convergence Insufficiency
FDA definition
A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
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 SBN

By decision year
1 clearance under product code SBN with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SBN by decision year
YearClearances
20241

Applicants with the most clearances

Product code SBN
Applicants holding the most 510(k) clearances under product code SBN
ApplicantClearances
Oculomotor Technologies1

Companies listing this code with FDA

Companies whose registered establishments list this code