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Forus Health PVT.LTD.: FDA-registered device maker in Bengaluru Karnataka, India, 2 510(k) clearances

Name: Forus Health PVT.LTD. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Forus Health PVT.LTD. is registered with the FDA (registration 3012162565) in Bengaluru Karnataka, India. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 14, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012162565
Address: No. 8, 27th Cross Rd, Banashankari Stage II, Banashankari, Bengaluru Karnataka, India, 560070
Owner or operator: FORUS HEALTH PVT.LTD. (10050919)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 18, 2016
Registered through: 2026
Brand names listed: 3nethra SL5-1000, 3nethra SL5-1000 Pro, 3nethra aberro, 3nethra classic, 3nethra classic 6.4, 3nethra classic HD, 3nethra classic+, 3nethra neo and more

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	PUE	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Manufacturer	accessdata.fda.gov
Camera, Ophthalmic, General-Use	PJZ	2	Manufacturer	accessdata.fda.gov
Photorefractor	MMF	2	Contract manufacturer	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Refractor, Manual, Non-Powered, Including Phoropter	HKN	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 14, 2025	K243600	3nethra neo HD FA; 3nethra neo HD	HKI	Substantially Equivalent	Forus Health Pvt.Ltd	accessdata.fda.gov
December 21, 2018	K183059	3nethra neo	HKI	Substantially Equivalent	Forus Health Pvt.Ltd	accessdata.fda.gov

Compare with other makers

Updated August 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.