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LZRClass II

Ultrasound, Cyclodestructive

21 CFR 886.5350 / Ophthalmic
FDA source (opens on fda.gov)

LZR is the FDA product code for Ultrasound, Cyclodestructive, a class II device type, regulated under 21 CFR 886.5350. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
LZR
Device name
Ultrasound, Cyclodestructive
FDA 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.
Regulation
21 CFR 886.5350
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LZR.