FDA product code HLD: Engine, Trephine, Accessories, Gas-Powered
HLD is the FDA product code for engine, trephine, accessories, gas-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. Devices under HLD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Engine, Trephine, Accessories, Gas-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HLD devices
openFDA lists no recalls for product code HLD.
Frequently asked questions
What is FDA product code HLD?
HLD is the FDA product code for engine, trephine, accessories, gas-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is HLD?
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 HLD
- Run a recall and safety report across every HLD manufacturer
- Watch product code HLD 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times