RM Electrode (RMH 25-01)

RM Electrode (RMH 25-01) is an FDA 510(k)-cleared medical device (K253586) manufactured by Retmap, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 2026. Regulation: 8.