FDA product code MMF: Photorefractor
MMF is the FDA product code for photorefractor. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under MMF. The average 510(k) review took 176 days (median 176).
Classification
| Field | Value |
|---|---|
| Device name | Photorefractor |
| Device class | Class II |
| Regulation | 21 CFR 886.1120 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MMF clearance
Top MMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Technology and Innovations, Inc. | 1 | 1994-04-06 |
Most recent MMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934880 | Medical Technology and Innovations, Inc. | MTI PHOTOSCREENER | 1994-04-06 | 176 |
Recalls for MMF devices
openFDA lists no recalls for product code MMF.
Frequently asked questions
What is FDA product code MMF?
MMF is the FDA product code for photorefractor. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel.
What device class is MMF?
Class II, regulation 21 CFR 886.1120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MMF?
Across 1 cleared submissions the average was 176 days from receipt to decision (median 176).
Which companies have the most MMF clearances?
Medical Technology and Innovations, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MMF
- Run a recall and safety report across every MMF manufacturer
- Watch product code MMF 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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