FDA product code LOH: System, Identification, Contact Lens
LOH is the FDA product code for system, identification, contact lens. It is a Class III device, reviewed by the Ophthalmic panel. Devices under LOH reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | System, Identification, Contact Lens |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOH devices
openFDA lists no recalls for product code LOH.
Frequently asked questions
What is FDA product code LOH?
LOH is the FDA product code for system, identification, contact lens. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is LOH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LOH
- Run a recall and safety report across every LOH manufacturer
- Watch product code LOH 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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