FDA product code HLZ: Electrode, Corneal
HLZ is the FDA product code for electrode, corneal. It is a Class II device, regulated under 21 CFR 886.1220 and reviewed by the Ophthalmic panel. FDA has cleared 11 510(k) submissions under HLZ, 2 in the last five years, from 10 different applicants. The average 510(k) review took 145 days (median 92); 135 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Corneal |
| Device class | Class II |
| Regulation | 21 CFR 886.1220 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HLZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 129 |
| 2026 | 1 | 135 |
Compare with all 510(k) review times · Search every HLZ clearance
Top HLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Retmap, Inc. | 2 | 2026-04-01 |
| Tomey Corporation USA | 1 | 1997-05-09 |
| Thomasville Medical Assoc. | 1 | 1994-02-25 |
| Doran Instruments, Inc. | 1 | 1992-01-31 |
| Sauquoit Industries, Inc. | 1 | 1985-02-14 |
5 more applicants have HLZ clearances. See the full list in Caduvo.
Most recent HLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253586 | Retmap, Inc. | RM Electrode (RMH 25-01) | 2026-04-01 | 135 |
| K232273 | Retmap, Inc. | RM Electrode (RMH 23-01) | 2023-12-07 | 129 |
| K961805 | Tomey Corporation USA | TOMEY DTL ELECTRODE | 1997-05-09 | 364 |
| K926540 | Thomasville Medical Assoc. | SOPHER AND BIERER OVUM FORCEPS | 1994-02-25 | 422 |
| K913239 | Doran Instruments, Inc. | GOLDLENS(TM) | 1992-01-31 | 193 |
Recalls for HLZ devices
openFDA lists no recalls for product code HLZ.
Frequently asked questions
What is FDA product code HLZ?
HLZ is the FDA product code for electrode, corneal. It is a Class II device, regulated under 21 CFR 886.1220 and reviewed by the Ophthalmic panel.
What device class is HLZ?
Class II, regulation 21 CFR 886.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code HLZ?
Across 11 cleared submissions the average was 145 days from receipt to decision (median 92).
Which companies have the most HLZ clearances?
Retmap, Inc. (2); Tomey Corporation USA (1); Thomasville Medical Assoc. (1); Doran Instruments, Inc. (1); Sauquoit Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLZ
- Run a recall and safety report across every HLZ manufacturer
- Watch product code HLZ 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.
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