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 |
|
hair removal
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