FDA product code HOL: Screen, Tangent, Felt (Campimeter)
HOL is the FDA product code for screen, tangent, felt (campimeter). It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel. Devices under HOL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Screen, Tangent, Felt (Campimeter) |
| Device class | Class I |
| Regulation | 21 CFR 886.1810 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HOL devices
openFDA lists no recalls for product code HOL.
Frequently asked questions
What is FDA product code HOL?
HOL is the FDA product code for screen, tangent, felt (campimeter). It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel.
What device class is HOL?
Class I, regulation 21 CFR 886.1810. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HOL
- Run a recall and safety report across every HOL manufacturer
- Watch product code HOL 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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