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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K252120
Device Name Fundus On Phone Non Mydriatic (FOP NM-10)
Applicant
Remidio Innovative Solutions Private Limited
# 1-51-2/12, Vacuum Techniques Compound
Peenya 1st Stage, Peenya
Bengaluru,  IN 560058
Applicant Contact Sundeep Agarwal
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number886.1120
Classification Product Code
HKI  
Date Received07/07/2025
Decision Date 12/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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