FDA product code LXR: Laser, Microsurgical Argon, For Use In Otology
LXR is the FDA product code for laser, microsurgical argon, for use in otology. It is a Class II device, regulated under 21 CFR 874.4490 and reviewed by the Ear, Nose and Throat panel. Devices under LXR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Laser, Microsurgical Argon, For Use In Otology |
| Device class | Class II |
| Regulation | 21 CFR 874.4490 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LXR devices
openFDA lists no recalls for product code LXR.
Frequently asked questions
What is FDA product code LXR?
LXR is the FDA product code for laser, microsurgical argon, for use in otology. It is a Class II device, regulated under 21 CFR 874.4490 and reviewed by the Ear, Nose and Throat panel.
What device class is LXR?
Class II, regulation 21 CFR 874.4490. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LXR
- Run a recall and safety report across every LXR manufacturer
- Watch product code LXR 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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