FDA product code OHX: Burr, Corneal, Ac-Powered, Rust Ring Removal
OHX is the FDA product code for burr, corneal, ac-powered, rust ring removal. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. Devices under OHX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.
Classification
| Field | Value |
|---|---|
| Device name | Burr, Corneal, Ac-Powered, Rust Ring Removal |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for OHX devices
openFDA lists no recalls for product code OHX.
Frequently asked questions
What is FDA product code OHX?
OHX is the FDA product code for burr, corneal, ac-powered, rust ring removal. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is OHX?
Class I, regulation 21 CFR 886.4070. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OHX
- Run a recall and safety report across every OHX manufacturer
- Watch product code OHX 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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