FDA product code HLE: Ruler, Nearpoint (Punctometer)
HLE is the FDA product code for ruler, nearpoint (punctometer). It is a Class I device, regulated under 21 CFR 886.1790 and reviewed by the Ophthalmic panel. Devices under HLE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ruler, Nearpoint (Punctometer) |
| Device class | Class I |
| Regulation | 21 CFR 886.1790 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HLE devices
openFDA lists no recalls for product code HLE.
Frequently asked questions
What is FDA product code HLE?
HLE is the FDA product code for ruler, nearpoint (punctometer). It is a Class I device, regulated under 21 CFR 886.1790 and reviewed by the Ophthalmic panel.
What device class is HLE?
Class I, regulation 21 CFR 886.1790. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HLE
- Run a recall and safety report across every HLE manufacturer
- Watch product code HLE 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.