Duns Number:545824560
Device Description: It is an AC-powered slit lamp Biomicroscopes intended for use in eye examination of the an It is an AC-powered slit lamp Biomicroscopes 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-1B
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
K182306,K182306,K182306,K182306,K182306
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
0a5b05d9-b89e-4f4b-b167-30763d4997c8
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
July 02, 2020
Package DI Number
26973211070378
Quantity per Package
2
Contains DI Package
06973211070381
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |