Biomicroscope, Slit-Lamp, Ac-Powered

The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a…

Registry build 21.09.26

The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient’s eye through a control diaphragm a thin, intense beam of light. The KH Ophthalmic Slit-lamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slit-lamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient’s eyes, and also can observe the three-dimensional image.

7manufacturers in China registered for this device type
3catalogue numbers in this listing

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 Biomicroscope, Slit-Lamp, Ac-Powered
Listed by Chongqing Kanghuaruiming S&T Co., Ltd..
FDA product code HJO
Device type Biomicroscope, Slit-Lamp, Ac-Powered
Device class Class 2
Regulation 21 CFR 886.1850
510(k) K171877
Record published 2018-03-21
Record revised 2022-12-20 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Biomicroscope, Slit-Lamp, Ac-Powered
Catalogue number Size Status
SLM-2ER In distribution
SLM-3ER In distribution
SLM-1ER 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

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