Duns Number:436887608
Device Description: The IMLIGHT CO2 Laser is a medical laser system equipped with a 40W CO2 laser source deliv The IMLIGHT CO2 Laser is a medical laser system equipped with a 40W CO2 laser source delivered through a hollow fiber.
Catalog Number
M103AK1
Brand Name
IMLIGHT CO2 Laser
Version/Model Number
M103AK1
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
K181867
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
f0a9a243-e669-4ffe-8d4e-4bd827eeb57b
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |