Duns Number:332247852
Device Description: Dermatological laser with the wavelengths 1064 nm, 532 nm, 585 nm and 694 nm. Intended for Dermatological laser with the wavelengths 1064 nm, 532 nm, 585 nm and 694 nm. Intended for the removal of tattoos, pigmented lesions, vascular lesions and skin resurfacing.
Catalog Number
-
Brand Name
TattooStar Effect COMBO
Version/Model Number
1680
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
K131757
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
e9df87fa-48c5-481b-9669-43ce13eca841
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
November 14, 2016
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 |