FDA product code PFZ: Ophthalmic Sealant
PFZ is the FDA product code for ophthalmic sealant. It is a Class III device, reviewed by the Ophthalmic panel. Devices under PFZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmic Sealant |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PFZ devices
openFDA lists no recalls for product code PFZ.
Frequently asked questions
What is FDA product code PFZ?
PFZ is the FDA product code for ophthalmic sealant. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is PFZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PFZ
- Run a recall and safety report across every PFZ manufacturer
- Watch product code PFZ 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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