Intense Pulsed Light Device For Managing Dry Eye

QIU · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5201

Classification

FDA Product Code: QIU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.5201
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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