Duns Number:688154202
Device Description: " -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)" -. The SLIT " -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)" -. The SLIT LAMP is intended for use in eye examination of the anterior eye segments, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Catalog Number
HS-7500(LED)
Brand Name
Slit Lamp HS-7500
Version/Model Number
HS-7500(LED)
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093639
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
ac5f76a2-d059-416a-a774-8426c8f29be7
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
May 10, 2019
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |