FDA 510(k) clearance: Microwave devices

FDA 510(k) clearances: Microwaves

Beginning in 1976, the US Food and Drug Administration (FDA) began requiring new medical devices to demonstrate they were substantially equivalent to a product marketed before 1976. FDA classifies microwave hair removal devices as follows:

  • Device Classification Name:
  • Regulation Number:
  • Product Code: MWY
  • Classification Advisory Committee: General & Plastic Surgery
  • Review Advisory Committee: General & Plastic Surgery

FDA: not for use on facial hair

On October 25, 1999, FDA stated about the only microwave device cleared to market:

Indications for use:

The Microwave Medical Corporation, Microwave Delivery System (Model MMC-300) is designed for the removal of unwanted body hair except on facial areas. [underline FDA’s]

This device is not for use on facial areas. Clinical data to date is not sufficient to demonstrate safety or effectiveness on facial areas.

This device was called the MMC-300 in its application but is currently marketed as the MW 2000.

I urge all practitioners and clients to avoid this device until there is more data on safety and effectiveness.

Product Code MWY

Microwave hair removal devices cleared by FDA since 1976:

Device Company Date cleared 510(k) #
MMC-300 MW Medical 10/25/99 K991456