RM Electrode (RMH 25-01)
FDA 510(k) K253586 · Retmap, Inc.
510(k) numberK253586
Submission
- Device name
- RM Electrode (RMH 25-01)
- Applicant
- Retmap, Inc.
Chicago, IL, US - Received
- November 17, 2025
- Decision date
- April 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLZ – Electrode, Corneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1220
- Specialty
- Ophthalmic
Other 510(k)s with product code HLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232273 | RM Electrode (RMH 23-01)HLZ · Traditional | Retmap, Inc. | 12/07/2023SE |
| K961805 | Tomey DTL ElectrodeHLZ · Traditional | Tomey Corporation USA | 05/09/1997SE |
| K926540 | Sopher and Bierer Ovum ForcepsHLZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K913239 | Goldlens(Tm)HLZ · Traditional | Doran Instruments, Inc. | 01/31/1992SE |
| K844409 | DTL ElectrodeHLZ · Traditional | Sauquoit Industries, Inc. | 02/14/1985SE |
| K830557 | Erg-Jet ElectrodeHLZ · Traditional | Universo S.A. | 03/31/1983SE |
| K820254 | Gold Foil Erg ElectrodesHLZ · Traditional | Cadwell Laboratories, Inc. | 04/09/1982SE |
| K813399 | Erg-Jet ElectrodeHLZ · Traditional | Nicolet Biomedical Instruments | 01/22/1982SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | Life-Tech Instruments, Inc. | 11/15/1978SE |
| K760199 | ElectroretinographHLZ · Traditional | Lkc Technologies, Inc. | 08/04/1976SE |
More from Lkc Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232273 | RM Electrode (RMH 23-01)HLZ · Traditional | 12/07/2023SE |
Questions and answers
When was RM Electrode (RMH 25-01) cleared by the FDA?
RM Electrode (RMH 25-01) (K253586) received a 510(k) decision of Substantially Equivalent on April 1, 2026, 135 days after the submission was received.
What is the product code of K253586?
The FDA product code is HLZ – Electrode, Corneal, a Class II (moderate risk) device regulated under 21 CFR 886.1220.