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) #|