Duns Number:644720625
Device Description: "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length."
Catalog Number
-
Brand Name
Fotona XP-2 Focus
Version/Model Number
M001-14F 2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K113702
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
0f442fb9-5018-407b-b893-67202e7e913f
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |