Duns Number:332247852
Device Description: Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo removal and the treatment of benign pigmented lesions as well as wrinkles and acne scars.
Catalog Number
-
Brand Name
PicoStar
Version/Model Number
M16-9510-000
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
K213889
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d2b69d49-ddbe-460a-b979-55fcd84f0af1
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 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 |