Duns Number:543066376
Device Description: The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intend 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 slitlamp 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.
Catalog Number
-
Brand Name
NA
Version/Model Number
SLM-3ER
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171877
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
807bc588-dce3-48dc-99af-e77460c6be2f
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
March 22, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |