Catalog Number

6659309

Brand Name

Sculpt I.Q.

Version/Model Number

6659309

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

fc33ee66-4e10-4bb0-a023-073b04274aa5

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

-