Duns Number:612920785
Device Description: PASCAL Synthesis SLC & ESF (577nm) for BM - IRIDEX
Catalog Number
SA-06197
Brand Name
PASCAL Synthesis, 577nm
Version/Model Number
Synthesis SLC & ESF 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
K123542
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
30ee034a-a4bd-43c9-a38f-d511a6aea1ad
Public Version Date
December 13, 2021
Public Version Number
1
DI Record Publish Date
December 05, 2021
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. | 177 |