Product code QZP

Device name

Camera, Ophthalmic, Non-Prescription

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.1120

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset