RM Electrode (RMH 25-01)— 510(k) K253586

Substantially Equivalent

Retmap, Inc.

FDA 510(k) clearance K253586 for RM Electrode (RMH 25-01), Substantially Equivalent on 2026-04-01. Applicant: Retmap, Inc.. Device class: 2.

Clearance details

Applicant: Retmap, Inc.
Product code: Code HLZ
Device class: Class 2
Regulation: 21 CFR 886.1220
Advisory panel: Ophthalmic
Date received: 2025-11-17
Decision date: 2026-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLZ

K232273 — RM Electrode (RMH 23-01)2023-12-07
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K926540 — SOPHER AND BIERER OVUM FORCEPS1994-02-25
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Data sourced from openFDA. This site is unofficial and independent of the FDA.