Who else makes this device?

Name: Optain
Brand: Optain

Ophthalmic › DiagnosticCamera, Ophthalmic, Ac-Powered

Optain

The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an…

Registry build 21.09.26

The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Chongqing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HKI
Manufacturer	City	Province	Registered as	Device types
Shanghai Mediworks Precision Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	13
Taizhou City K&W International Trade Co., Ltd.	Jiangyan	Jiangsu	Repacker / relabeller	38
Chongqing BIO Newvision Medical Equipment Ltd.	Chongqing	Chongqing	Manufacturer	2

Record

Regulatory record for Optain
Listed by	Optain Health, United States
FDA product code	HKI
Device type	Camera, Ophthalmic, Ac-Powered
Device class	Class 2
Regulation	21 CFR 886.1120
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K250683
Record published	2025-07-07

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Optain
Catalogue number	Size	Status
Resolve Fundus Camera		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Jedmed	Jedmed Instrument Company	15
Neolight	Neolight, LLC	11
Natus	Xltek	6
RetCam Envision	Natus Medical Denmark ApS	6
3nethra	Forus Health Pvt.ltd.,	6
iCam	Optovue, Inc.	5
iFusion	Optovue, Inc.	5
Canon Inc.	Canon Inc.	4
Camera, Ophthalmic, Ac-Powered	Chongqing Kanghuaruiming S&T Co., Ltd..	4
3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2)	Topcon Corp.	3
Retinal Camera TRC-50DX	Topcon Corp.	3
NON-Mydriatic Retinal Camera TRC-NW400	Topcon Corp.	2

Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250683	2025-04-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.