K253586
- 510(k) number
- K253586
- Device name
- RM Electrode (RMH 25-01)
- Applicant
- Retmap, Inc. IL · US
- Product code
- HLZ — Electrode, Corneal
- Decision date
- 2026-04-01
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253586.pdf
Official FDA record: K253586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.