Duns Number:057015198
Device Description: Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments to impro Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a stand alone device to improve the appearance of cellulite.
Catalog Number
1004900-MDC-003
Brand Name
Resonic
Version/Model Number
Rapid Acoustic Pulse Device (RAP) GEN-2.2
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210964
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
aebd4a3d-8a0c-4cdb-afd6-c6c4df738829
Public Version Date
November 10, 2021
Public Version Number
1
DI Record Publish Date
November 02, 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. | 1 |