FDA product code HML: Euthyscope, Battery-Powered
HML is the FDA product code for euthyscope, battery-powered. It is a Class I device, regulated under 21 CFR 886.1250 and reviewed by the Ophthalmic panel. Devices under HML reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Euthyscope, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1250 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HML devices
openFDA lists no recalls for product code HML.
Frequently asked questions
What is FDA product code HML?
HML is the FDA product code for euthyscope, battery-powered. It is a Class I device, regulated under 21 CFR 886.1250 and reviewed by the Ophthalmic panel.
What device class is HML?
Class I, regulation 21 CFR 886.1250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HML
- Run a recall and safety report across every HML manufacturer
- Watch product code HML 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.