Duns Number:532396673
Device Description: IPL (Intense Pulsed Light ) Applicator to be used with Formatk Systems Ltd supporting syst IPL (Intense Pulsed Light ) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Pigmented lesions and removal of unwanted hair
Catalog Number
FS90015
Brand Name
L-650
Version/Model Number
FS90015
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
K183307
Product Code
ONF
Product Code Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Public Device Record Key
4d986144-971b-4623-b7ba-452e61ab1cab
Public Version Date
January 16, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2018
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 |