Catalog Number

-

Brand Name

MISMON

Version/Model Number

MS-206B

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180016,K180016

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Public Device Record Key

e1f5dcdd-c0a8-4903-b10b-f0e0f7efe27a

Public Version Date

October 19, 2018

Public Version Number

1

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-