Catalog Number

6659291

Brand Name

Sculpt I.Q.

Version/Model Number

6659291

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

Yes

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,K170500

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

d941caa1-1dca-46c2-8bb0-d27698f21e6e

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

-