FDA product code MUS: Fluidic, Phacoemulsification/Phacofragmentation
MUS is the FDA product code for fluidic, phacoemulsification/phacofragmentation. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under MUS. The average 510(k) review took 113 days (median 113).
Classification
| Field | Value |
|---|---|
| Device name | Fluidic, Phacoemulsification/Phacofragmentation |
| 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 |
Compare with all 510(k) review times · Search every MUS clearance
Top MUS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alcon Laboratories | 1 | 1998-05-19 |
Most recent MUS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980292 | Alcon Laboratories | CATARACT LIQUEFRACTURE DEVICE | 1998-05-19 | 113 |
Recalls for MUS devices
openFDA lists no recalls for product code MUS.
Frequently asked questions
What is FDA product code MUS?
MUS is the FDA product code for fluidic, phacoemulsification/phacofragmentation. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel.
What device class is MUS?
Class II, regulation 21 CFR 886.4670. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUS?
Across 1 cleared submissions the average was 113 days from receipt to decision (median 113).
Which companies have the most MUS clearances?
Alcon Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MUS
- Run a recall and safety report across every MUS manufacturer
- Watch product code MUS 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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