Duns Number:266012441
Device Description: Exci308® by AerolaseThis medical device is intended to be used for the treatment of psoria Exci308® by AerolaseThis medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.Excimer light source, wavelength 308nm, optical power 2500 mW.
Catalog Number
EIPL-PRD-K01-exci308
Brand Name
EXCI308 by Aerolase
Version/Model Number
EIPL-100
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
K191086
Product Code
FTC
Product Code Name
Light, Ultraviolet, Dermatological
Public Device Record Key
58f9eb47-b6ac-4b9a-91dd-88f5d58d441d
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 13, 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. | 2 |