Catalog Number

-

Brand Name

RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLY

Version/Model Number

R100-7026-910

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

K171992

Product Code

PKT

Product Code Name

Laser for disruption of adipocyte cells for aesthetic use

Public Device Record Key

f72a9515-8f2c-42c3-95d9-c08ab6af89e2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-