# K243600: 3nethra neo HD FA; 3nethra neo HD

- Pathway: 510(k) (Traditional)
- Applicant: Forus Health Pvt.Ltd
- Decided: Aug 14, 2025 after 266 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K081858 (2008). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183059: 3nethra neo, Forus Health Pvt.Ltd (2018) Summary page 5.

## Indications for use
3nethra neo HD FA is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment. 3nethra neo HD is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.

Source page: https://510kreport.com/device/K243600
Methodology: https://510kreport.com/methodology