The following was sent by Richard Felten at FDA in response to question about the SpaTouch by Radiancy:
</font><blockquote><font size=“1” face=“Verdana, Helvetica, sans-serif”>quote:</font><hr /><font size=“2” face=“Verdana, Helvetica, sans-serif”> The device was cleared for marketing as a Prescription Home-use device. This means that in order to purchase the device the individual needs a prescription from his or her physician just as is required for prescription drugs.
The statement under the direction of physician or healthcare professional means that the physician or a person within the physician’s practice is responsible for training the individual how to use the device. We do not define “healthcare professional”.
The individual received hands-on training from the physician and, based on the recommendations within the instructions for use in the device manual, the physician is responsible in helping the individual establish the safe and effective settings needed for that individual’s hair type and color. The company provided clinical trial data showing that when the physician provided the instructions for use and guidance the individual could safely and effectively remove hair under at home conditions.
Our clearance does not mean this device is superior to other systems and in fact we would grant similar clearances for other systems if the provide data to support home use. Also the phrase “Physician Directed Use” was coined by the company and has not meaning under our regulations.
Richard Felten </font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>