3nethra neo HD FA; 3nethra neo HD

FDA 510(k) K243600 · Forus Health Pvt.Ltd

Substantially Equivalent

510(k) numberK243600

Submission

Device name
3nethra neo HD FA; 3nethra neo HD
Applicant
Forus Health Pvt.Ltd
Bengaluru, IN
Received
November 21, 2024
Decision date
August 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HKI – Camera, Ophthalmic, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1120
Specialty
Ophthalmic

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Questions and answers

When was 3nethra neo HD FA; 3nethra neo HD cleared by the FDA?

3nethra neo HD FA; 3nethra neo HD (K243600) received a 510(k) decision of Substantially Equivalent on August 14, 2025, 266 days after the submission was received.

What is the product code of K243600?

The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.