Duns Number:533127663
Device Description: IPL applicator indicated for the removal of unwanted hair and to effect stable long-term o IPL applicator indicated for the removal of unwanted hair and to effect stable long-term orpermanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in thenumber of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Catalog Number
-
Brand Name
HR650 applicator
Version/Model Number
AS120031
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
K153717,K153717
Product Code
ONF
Product Code Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Public Device Record Key
268a323f-808a-4e15-b8ff-2488ea584880
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
07290016540529
Quantity per Package
1
Contains DI Package
07290016540413
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. | 55 |