Camera, Ophthalmic, Non-Prescription

QZP · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1120

Classification

FDA Product Code: QZP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.1120
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

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