Duns Number:462514006
Device Description: PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators i PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include:• Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.• Treatment of Pseudofolliculitis barbae (PFB)
Catalog Number
521028
Brand Name
primelase excellence
Version/Model Number
PRIMELASE diode laser hair removal system
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
K191321
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
5cf28e19-e6d0-429b-b1ad-fe92b8c6befb
Public Version Date
April 17, 2020
Public Version Number
1
DI Record Publish Date
April 09, 2020
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. | 2 |