Duns Number:554415413
Device Description: IPL HAIR REMOVAL DEVICE
Catalog Number
-
Brand Name
Aymo
Version/Model Number
Aymo Beauty D50 148Q-BD50XX-USDG0A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHT
Product Code Name
Light Based Over-The-Counter Hair Removal
Public Device Record Key
229ba507-c012-4ef4-affa-8ad16065d552
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 2021
Package DI Number
16973504240016
Quantity per Package
10
Contains DI Package
06973504240019
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |