HLZ
- Product code
- HLZ
- Device name
- Electrode, Corneal
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1220
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253586 | 2026-04-01 | Retmap, Inc. | RM Electrode (RMH 25-01) | |
| K232273 | 2023-12-07 | Retmap, Inc. | RM Electrode (RMH 23-01) |
Official FDA classification page: HLZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).