Catalog Number

-

Brand Name

ASSY, MASK, Petite, Submental Adapter

Version/Model Number

100-7026-826

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

K182741

Product Code

PKT

Product Code Name

Laser for disruption of adipocyte cells for aesthetic use

Public Device Record Key

4ff4a0e3-c019-41e5-8905-d0f51c3a0926

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-