Ocular Pattern Recorder

PLZ · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1925

Classification

FDA Product Code: PLZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.1925
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

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

Source

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