3nethra neo HD FA— 510(k) K243600

Substantially Equivalent

Forus Health Pvt.Ltd

FDA 510(k) clearance K243600 for 3nethra neo HD FA, Substantially Equivalent on 2025-08-14. Applicant: Forus Health Pvt.Ltd. Device class: 2.

Clearance details

Device name as filed
3nethra neo HD FA; 3nethra neo HD
Applicant
Forus Health Pvt.Ltd
Product code
Code HKI
Device class
Class 2
Regulation
21 CFR 886.1120
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bengaluru, IN
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