Product code LZR

Device name

Ultrasound, Cyclodestructive

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5350

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset