FDA product code MMC: Dilator, Expansive Iris (Accessory)
MMC is the FDA product code for dilator, expansive iris (accessory). It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel. Devices under MMC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Expansive Iris (Accessory) |
| Device class | Class II |
| Regulation | 21 CFR 886.4150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MMC devices
openFDA lists no recalls for product code MMC.
Frequently asked questions
What is FDA product code MMC?
MMC is the FDA product code for dilator, expansive iris (accessory). It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel.
What device class is MMC?
Class II, regulation 21 CFR 886.4150. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MMC
- Run a recall and safety report across every MMC manufacturer
- Watch product code MMC 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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