Duns Number:332247852
Device Description: Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporizatio Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Catalog Number
-
Brand Name
MCL 31 Dermablate
Version/Model Number
1823
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
K150140
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
a2a0d6e3-81b5-4f92-aaee-c6f059061b5c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 30, 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. | 46 |