| K-number | K253586 |
| Device name | RM Electrode (RMH 25-01) |
| Applicant | Retmap, Inc. |
| Product code | HLZ |
| Device class | Class II |
| Decision date | Apr 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 886.1220 |
The RM Electrode (RMH 25-01) is a single-use, disposable contact lens electrode placed on the cornea to measure and record electroretinography (ERG) signals. It supports diagnosis of retinal dysfunctions in patients aged 12 years and above undergoing full-field and multi-focal ERG recording procedures.
The subject device has four components: a soft silicone contact lens substrate, a recessed electrode ring, a lead wire terminating in a 1.5mm female touchproof connector, and heat shrink tubing. It includes optical characteristics suitable for multi-focal ERG testing and a shape feature to distinguish the eye-contact side from the distal side. The device is a passive sensor with substantially equivalent electrical impedance, lead wire integrity, and optical properties to the predicate devices.
ISO 10993-23 (ocular irritation testing in rabbits), ISCEV LA 3.0 stimulus protocols for ERG testing, IEC 60601-1 (electrical safety standards for compatible ERG recorders), and ISCEV standards for clinical electroretinography with multi-focal stimuli.
The subject device is substantially equivalent to the primary predicate RM Electrode (K232273) and secondary predicate ERG Jet Electrode (K813399) based on identical intended use, nearly identical technological characteristics and design, and performance testing demonstrating equivalent ERG signal quality, electrical impedance, material biocompatibility, and ocular safety. Clinical testing in humans and bench testing confirmed equivalence in full-field and multi-focal ERG procedures.
View the full FDA submission: accessdata.fda.gov