Digital Therapy Device For Convergence Insufficiency

SBN · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1290

Classification

FDA Product Code: SBN
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 886.1290
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown