FDA product code HLC: Instrument, Measuring, Stereopsis
HLC is the FDA product code for instrument, measuring, stereopsis. It is a Class I device, regulated under 21 CFR 886.1460 and reviewed by the Ophthalmic panel. Devices under HLC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Measuring, Stereopsis |
| Device class | Class I |
| Regulation | 21 CFR 886.1460 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HLC devices
openFDA lists no recalls for product code HLC.
Frequently asked questions
What is FDA product code HLC?
HLC is the FDA product code for instrument, measuring, stereopsis. It is a Class I device, regulated under 21 CFR 886.1460 and reviewed by the Ophthalmic panel.
What device class is HLC?
Class I, regulation 21 CFR 886.1460. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HLC
- Run a recall and safety report across every HLC manufacturer
- Watch product code HLC 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.