FDA product code PYU: Sponge, Eyelid Cleaning, Powered
PYU is the FDA product code for sponge, eyelid cleaning, powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Ophthalmic panel. Devices under PYU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional.
Classification
| Field | Value |
|---|---|
| Device name | Sponge, Eyelid Cleaning, Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | OP — Ophthalmic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for PYU devices
openFDA lists no recalls for product code PYU.
Frequently asked questions
What is FDA product code PYU?
PYU is the FDA product code for sponge, eyelid cleaning, powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Ophthalmic panel.
What device class is PYU?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PYU
- Run a recall and safety report across every PYU manufacturer
- Watch product code PYU 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.