Duns Number:436887608
Device Description: The LipoAI is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The d The LipoAI is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin.
Catalog Number
M131A1
Brand Name
DEKA LIPOAI
Version/Model Number
M131A1
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
K212270
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d7cb675a-f509-4d4b-ba7b-a36d57846d96
Public Version Date
April 13, 2022
Public Version Number
1
DI Record Publish Date
April 05, 2022
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 |