Duns Number:545824560
Device Description: It is an AC-powered slit lamp Bio-microscope intended for use in eye examination of the an It is an AC-powered slit lamp Bio-microscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment
Catalog Number
-
Brand Name
Ophthalmic Slit Lamp Microscope
Version/Model Number
LS-5C
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"
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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
-
Product Code
PUE
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
Public Device Record Key
0960f445-db46-4063-b733-5fdde80601e0
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
July 02, 2020
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |