FDA product code LZS: Excimer Laser System
LZS is the FDA product code for excimer laser system. It is a Class III device, reviewed by the Ophthalmic panel. Devices under LZS reach the market by PMA; FDA lists no cleared 510(k)s for it. 15 PMA applications cite this product code. FDA has posted 29 recalls for LZS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Excimer Laser System |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LZS devices
29 product recalls in 14 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2021-10-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code LZS?
LZS is the FDA product code for excimer laser system. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is LZS?
Class III. Typical premarket route: PMA.
Have LZS devices been recalled?
Yes: 29 product recalls across 14 recall events; the most recent began 2021-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LZS
- Run a recall and safety report across every LZS manufacturer
- Watch product code LZS 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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