Duns Number:532396673
Device Description: DioBreeze system supporting Laser applicators indicated for various treatments such as Hai DioBreeze system supporting Laser applicators indicated for various treatments such as Hair Removal, Permanent Hair Reduction and pseudofolliculitis barbae (PFB)
Catalog Number
FS80020
Brand Name
DioBreeze
Version/Model Number
FS80020
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
K162781
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
985f17e9-2654-48c6-9897-88fd5798306c
Public Version Date
July 05, 2021
Public Version Number
1
DI Record Publish Date
June 25, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |