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510(k) K253586

RM Electrode (RMH 25-01) by Retmap, Inc. — Product Code HLZ

K253586 is an FDA 510(k) premarket notification submitted by Retmap, Inc. for the device "RM Electrode (RMH 25-01)". The FDA issued a decision of Substantially Equivalent on April 1, 2026. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Retmap, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type

Other clearances by Retmap, Inc.

  • K232273 — RM Electrode (RMH 23-01) (December 7, 2023)

Other clearances for product code HLZ

  • K232273 — RM Electrode (RMH 23-01) (December 7, 2023)
  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K913239 — GOLDLENS(TM) (January 31, 1992)
  • K844409 — DTL ELECTRODE (February 14, 1985)
  • K830557 — ERG-JET ELECTRODE (March 31, 1983)
  • K820254 — GOLD FOIL ERG ELECTRODES (April 9, 1982)
  • K813399 — ERG-JET ELECTRODE (January 22, 1982)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

FDA data resources