Duns Number:152165700
Device Description: A starter kit containing 10 single-use pre-initiated laser tips intended for use with Epic A starter kit containing 10 single-use pre-initiated laser tips intended for use with Epic Pro Diode Laser Systems. The tips have the same length of 4 mm and core diameters of 300 and 400 µm.
Catalog Number
6400605
Brand Name
Diode Laser Tips
Version/Model Number
PI Pro Tips, Starter Kit
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
Yes
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
K163128
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
3029f72d-06ca-4dbd-bcbe-c58db517df87
Public Version Date
July 29, 2020
Public Version Number
5
DI Record Publish Date
May 21, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |