FDA product code PUF: Ocular Peg, Exempt
PUF is the FDA product code for ocular peg, exempt. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel. Devices under PUF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Ocular Peg, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 886.3320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Recalls for PUF devices
openFDA lists no recalls for product code PUF.
Frequently asked questions
What is FDA product code PUF?
PUF is the FDA product code for ocular peg, exempt. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel.
What device class is PUF?
Class II, regulation 21 CFR 886.3320. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PUF
- Run a recall and safety report across every PUF manufacturer
- Watch product code PUF 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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