Visuref 600

VISUREF 600 combines automatic refraction and keratometry with tools for examining the anterior eye. It measures refractive power and corneal curvature and supports observation of lens…

Registry build 21.09.26

VISUREF 600 combines automatic refraction and keratometry with tools for examining the anterior eye. It measures refractive power and corneal curvature and supports observation of lens opacity, tear film breakup and meibomian glands. A chinrest supports the patient while the measurement unit acquires the information.

The device uses light sources, sensors and a camera to measure and display eye structures. Retroillumination supports lens opacity assessment, infrared illumination images the eyelid glands, and tear film breakup time is measured from the last complete blink to the appearance of dark areas in a fluorescein filled tear film.

Controls and Output

A display and joystick control device operation, and an integrated printer produces measurement results. The measurement functions include sphere, cylinder and axis for refraction and central and peripheral corneal curvature.

7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HJO
Manufacturer City Province Registered as Device types
Chongqing Kanghua Ruiming S&T Co., Ltd. Chongqing Chongqing Contract manufacturer 3
Beijing Hongdee Corporation Beijing Beijing Private-label distributor 43
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
66 Vision Tech Co., Ltd. Suzhou Jiangsu Private-label distributor 24
Shanghai Mediworks Precision Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 13
Chongqing Sunkingdom Medical Instrument Co., Ltd. Chongqing Chongqing Manufacturer 11

Record

Regulatory record for Visuref 600
Listed by Carl Zeiss Vision Gmbh, Germany
FDA product code HJO
Device type Biomicroscope, Slit-Lamp, Ac-Powered
Device class Class 2
Regulation 21 CFR 886.1850
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k) K253834
Record published 2026-04-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Visuref 600
Catalogue number Size Status
000000-2572-424 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MediWorks Shanghai Mediworks Precision Instruments Co., Ltd. 30
S4 Optik Costruzioni Strumenti Oftalmici C.S.O. SRL 24
Marco Takagi Seiko Co., Ltd. 17
Gilras U.S. Ophthalmic, L.L.C. 16
Visionix Luneau Technology Operations 15
LED Slit Lamp Right MFG. Co., Ltd. 13
Tiannuo / Tnmed Lianyungang Tiannuo Optical Instrument Co., Ltd. 12
Eli Ezer U.S. Ophthalmic, L.L.C. 12
Inami Inami & Co., Ltd. 11
Zoom Slit Lamp Right MFG. Co., Ltd. 8
Slit Lamp BQ 900 Haag-Streit AG 8
PolyLock Small Bone Fusion Orthopedics, LLC 7

Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K253834 2026-03-18

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer