Duns Number:462514006
Device Description: ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Ha ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Hair Removal withStatic and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in thenumber of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment ofPseudofolliculitis barbae (PFB)
Catalog Number
522040
Brand Name
elysion-pro
Version/Model Number
ELYSION 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
K193367
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
6e6297b5-8820-4d9f-b4a1-6cfa0e962f55
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 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 |