FDA product code LZR: Ultrasound, Cyclodestructive
LZR is the FDA product code for ultrasound, cyclodestructive. It is a Class II device, regulated under 21 CFR 886.5350 and reviewed by the Ophthalmic panel. Devices under LZR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound, Cyclodestructive |
| Device class | Class II |
| Regulation | 21 CFR 886.5350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for LZR devices
openFDA lists no recalls for product code LZR.
Frequently asked questions
What is FDA product code LZR?
LZR is the FDA product code for ultrasound, cyclodestructive. It is a Class II device, regulated under 21 CFR 886.5350 and reviewed by the Ophthalmic panel.
What device class is LZR?
Class II, regulation 21 CFR 886.5350. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LZR
- Run a recall and safety report across every LZR manufacturer
- Watch product code LZR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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