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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 K243600
Device Name 3nethra neo HD FA; 3nethra neo HD
Applicant
Forus Health Pvt.Ltd
# 8, 27th Cross Rd., Banashankari Stage Ii, Banashankari
Bengaluru,  IN 560070
Applicant Contact RJ Venkataramanan
Correspondent
Forus Health Pvt.Ltd
# 8, 27th Cross Rd., Banashankari Stage Ii, Banashankari
Bengaluru,  IN 560070
Correspondent Contact RJ Venkataramanan
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/21/2024
Decision Date 08/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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