FDA product code HIY: Brush, Haidinger, (Including Macular Integrity)
HIY is the FDA product code for brush, haidinger, (including macular integrity). It is a Class I device, regulated under 21 CFR 886.1090 and reviewed by the Ophthalmic panel. Devices under HIY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Brush, Haidinger, (Including Macular Integrity) |
| Device class | Class I |
| Regulation | 21 CFR 886.1090 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HIY devices
openFDA lists no recalls for product code HIY.
Frequently asked questions
What is FDA product code HIY?
HIY is the FDA product code for brush, haidinger, (including macular integrity). It is a Class I device, regulated under 21 CFR 886.1090 and reviewed by the Ophthalmic panel.
What device class is HIY?
Class I, regulation 21 CFR 886.1090. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HIY
- Run a recall and safety report across every HIY manufacturer
- Watch product code HIY 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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