Cleared Traditional

3nethra neo HD FA; 3nethra neo HD

K243600 · Forus Health Pvt.Ltd · Ophthalmic

Aug 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K243600 is an FDA 510(k) clearance for the 3nethra neo HD FA; 3nethra neo HD, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Forus Health Pvt.Ltd (Bengaluru, IN). The FDA issued a Cleared decision on August 14, 2025, 266 days after receiving the submission on November 21, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K243600 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2024
Decision Date	August 14, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF