PLZ

Ocular Pattern Recorder

Product code

PLZ

Device name

Ocular Pattern Recorder

Device class

Class 2

21 CFR

21 CFR 886.1925

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).