Duns Number:532396673
Device Description: IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting syste
Catalog Number
FS10007
Brand Name
B-HR*
Version/Model Number
FS10007
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
K153566,K160195
Product Code
ONF
Product Code Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Public Device Record Key
0851bd38-52f7-4693-becb-80acca8709bd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 2017
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 |