FDA product code HMZ: Trabeculotome
HMZ is the FDA product code for trabeculotome. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. Devices under HMZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for HMZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Trabeculotome |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HMZ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-09-06.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code HMZ?
HMZ is the FDA product code for trabeculotome. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HMZ?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
Have HMZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-09-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HMZ
- Run a recall and safety report across every HMZ manufacturer
- Watch product code HMZ 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