LZR — Ultrasound, Cyclodestructive Class II

FDA Device Classification

Classification Details

Product Code: LZR
Device Class: Class II
Regulation Number: 886.5350
Submission Type
Review Panel: OP
Medical Specialty: Ophthalmic
Implant: No

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.