Duns Number:332247852
Device Description: Dermatological laser with 532 nm. Intended for the treatment of benign vascular and pigmen Dermatological laser with 532 nm. Intended for the treatment of benign vascular and pigmented lesions. (prepared for scanner adaption)
Catalog Number
-
Brand Name
QuadroStar PRO
Version/Model Number
1491
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
K133297
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
735fa4d9-ff83-4b75-be52-88a142d5efeb
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 17, 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 |