FDA product code MXO: Laser, System, Phacolysis
MXO is the FDA product code for laser, system, phacolysis. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel. Devices under MXO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Laser, System, Phacolysis |
| Device class | Class II |
| Regulation | 21 CFR 886.4670 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MXO devices
openFDA lists no recalls for product code MXO.
Frequently asked questions
What is FDA product code MXO?
MXO is the FDA product code for laser, system, phacolysis. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel.
What device class is MXO?
Class II, regulation 21 CFR 886.4670. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MXO
- Run a recall and safety report across every MXO manufacturer
- Watch product code MXO 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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