Cleared Traditional

RM Electrode (RMH 23-01)

K232273 · Retmap, Inc. · Ophthalmic

Dec 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K232273 is an FDA 510(k) clearance for the RM Electrode (RMH 23-01), a Electrode, Corneal (Class II — Special Controls, product code HLZ), submitted by Retmap, Inc. (Chicago, US). The FDA issued a Cleared decision on December 7, 2023, 129 days after receiving the submission on July 31, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1220.

Submission Details

510(k) Number	K232273 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2023
Decision Date	December 07, 2023
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF