Duns Number:801157132
Device Description: Upgrade Package, 660nm wavelength
Catalog Number
6661420
Brand Name
Sculpt I.Q.
Version/Model Number
6661420
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2018
Issuing Agency
In HIBCC
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
K170500
Product Code
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
aa83552d-e519-4d9f-8eca-6644b06aef47
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
March 14, 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 | 66 |
2 | A medical device with a moderate to high risk that requires special controls. | 103 |
U | Unclassified | 13 |