FDA product code HOA: Compressor, Orbital
HOA is the FDA product code for compressor, orbital. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. Devices under HOA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Compressor, Orbital |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HOA devices
openFDA lists no recalls for product code HOA.
Frequently asked questions
What is FDA product code HOA?
HOA is the FDA product code for compressor, orbital. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HOA?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HOA
- Run a recall and safety report across every HOA manufacturer
- Watch product code HOA 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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