Ultrasound, Cyclodestructive

LZR · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5350

Classification

FDA Product Code: LZR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.5350
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An ultrasound cyclodestructive device uses high intensity focused ultrasound (HIFU) energy to create lesions in the ciliary body and/or trabecular meshwork to reduce intraocular pressure in glaucoma patients.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

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