Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

SAX · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1600

Classification

FDA Product Code: SAX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.1600
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments.

Market data

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

Source

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