Home-use laser cleared by FDA

Andrea · November 3, 2002, 12:37pm

The following was sent by Richard Felten at FDA in response to question about the SpaTouch by Radiancy:

<blockquote>quote:<hr /> 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 <hr /></blockquote>

shaun · December 5, 2002, 8:22am

do you know if they work or how much they would cost??

Andrea · December 8, 2002, 1:55am

They may work on some dark hairs, but they are very low power and will probably not cause a permanent result.

They cost around US$8,000 used.

James_W_Walker_VII · December 31, 2002, 2:56pm

I guess they have to find a market for all the reposessed units they are reaccumulating

pattycake · February 24, 2004, 5:14am

ugh!!! 8000 is a lot of money

sparx · February 15, 2006, 5:11pm

The following was sent by Richard Felten at FDA in response to question about the SpaTouch by Radiancy:

<blockquote>quote:<hr /> 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 <hr /></blockquote>

“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.”

Like people can buy prescription drugs on the net who writes those out <img src="/ubbthreads/images/graemlins/confused.gif" alt="" /> - and there are plenty of mexican and russian physicians about <img src="/ubbthreads/images/graemlins/smile.gif" alt="" />

James_W_Walker_VII · February 16, 2006, 1:03am

And remember, clearance to market only means we don’t think it will kill you. It doesn’t mean the FDA thinks it will work.