Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Electrode, Corneal
510(k) Number K253586
Device Name RM Electrode (RMH 25-01)
Applicant
Retmap, Inc.
832 W Superior St., Suite 302
Chicago,  IL  60642
Applicant Contact Shresta Patangay
Correspondent
Retmap, Inc.
832 W Superior St., Suite 302
Chicago,  IL  60642
Correspondent Contact Shresta Patangay
Regulation Number886.1220
Classification Product Code
HLZ  
Date Received11/17/2025
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Clinical Trials NCT05509608
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-