Product code PLZ

Device name

Ocular Pattern Recorder

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.1925

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.

Source

FDA openFDA device classification dataset