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3nethra neo HD FA; 3nethra neo HD

by Forus Health Pvt.Ltd

510(k) K243600

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243600 Date14 Aug 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HKI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a camera, ophthalmic, AC-powered, intended for use in ophthalmic imaging. It is a wide-field retinal imaging system designed for neonatal and pediatric ophthalmology, specifically for diagnosing and monitoring ocular diseases in newborn infants, including retinopathy of prematurity screening.

The device is supplied as a compact, portable, and user-friendly system for use in clinical settings such as neonatal intensive care units and pediatric ophthalmology clinics. It is AC-powered and requires no sterility or single-use designation as it is a reusable imaging system. The device received FDA 510(k) clearance (K243600) as substantially equivalent to a predicate device, with product code HKI and regulation number 886.1120, and is manufactured by Forus Health Pvt. Ltd. in Bengaluru, India.

Other devices from Forus Health Pvt.Ltd

  • 3nethra neo

    Class II

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 3nethra neo HD FA used for?

    The 3nethra neo HD FA is intended for ophthalmic imaging in neonatal and pediatric patients, specifically designed to diagnose and monitor ocular diseases such as retinopathy of prematurity in newborn infants by capturing wide-field retinal images.

  • Is the 3nethra neo HD FA a sterile or single-use device?

    No, the 3nethra neo HD FA is not sterile or single-use; it is a reusable AC-powered imaging system that does not require sterility precautions as it is designed for repeated clinical use in settings like NICUs and pediatric clinics.

  • How is the 3nethra neo HD FA powered and where is it typically used?

    The device is AC-powered and supplied as a compact, portable system intended for use in clinical environments such as neonatal intensive care units and pediatric ophthalmology clinics, where it supports wide-field retinal imaging for infant patients.