Duns Number:041376321
Device Description: KIT, PASCAL LIO, 577nm, PASCAL SYNTHESIS D RELEASE
Catalog Number
SA-06172
Brand Name
PASCAL Laser Indirect Ophthalmoscope
Version/Model Number
LIO for Synthesis 577
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
K123056
Product Code
HQF
Product Code Name
Laser, ophthalmic
Public Device Record Key
2b6bc048-f65b-4298-8488-8d1d234c6ea8
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
April 15, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |