Duns Number:532396673
Device Description: Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal t Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
Catalog Number
FS7007
Brand Name
LLD
Version/Model Number
FS70007
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
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
5770b398-dd54-4486-8b76-a8873b29943b
Public Version Date
May 24, 2021
Public Version Number
4
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 |