Catalog Number

3159

Brand Name

HAIR REMOVAL LASER

Version/Model Number

HRL 4X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090820

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c5579d7a-b6e9-4563-a355-cfa00f6ca5cf

Public Version Date

July 21, 2020

Public Version Number

1

DI Record Publish Date

July 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-