Duns Number:436887608
Device Description: The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DE The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip.
Catalog Number
M128A1
Brand Name
DEKA SMARTPERIO
Version/Model Number
M128A1
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
K213658
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
3b48e06b-2891-47d1-9b4c-a65b79c53daa
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 |