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#11508 - 11/03/02 12:37 PM Home-use laser cleared by FDA
Andrea Offline
hairtell.com founder
Top 10 Contributor

Registered: 03/22/02
Posts: 4146
Loc: Los Angeles
The following was sent by Richard Felten at FDA in response to question about the SpaTouch by Radiancy:



quote:
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


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#11509 - 12/05/02 08:22 AM Re: Home-use laser cleared by FDA
shaun Offline
Member

Registered: 12/04/02
Posts: 10
do you know if they work or how much they would cost??

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#11510 - 12/08/02 01:55 AM Re: Home-use laser cleared by FDA
Andrea Offline
hairtell.com founder
Top 10 Contributor

Registered: 03/22/02
Posts: 4146
Loc: Los Angeles
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.

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#11511 - 12/31/02 02:56 PM Re: Home-use laser cleared by FDA
James W. Walker VII Offline

Top 10 Contributor

Registered: 06/03/02
Posts: 8027
Loc: Buffalo NY, & Traveling the US...
I guess they have to find a market for all the reposessed units they are reaccumulating [Razz]

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#11512 - 02/24/04 05:14 AM Re: Home-use laser cleared by FDA
pattycake Offline
Member

Registered: 02/21/04
Posts: 11
Loc: birmingham
ugh!!!!! 8000 is a lot of money

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#11513 - 02/15/06 05:11 PM Re: Home-use laser cleared by FDA
sparx Offline
Major Contributor

Registered: 02/15/06
Posts: 71
Quote:

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">








"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 - and there are plenty of mexican and russian physicians about

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#11514 - 02/16/06 01:03 AM Re: Home-use laser cleared by FDA
James W. Walker VII Offline

Top 10 Contributor

Registered: 06/03/02
Posts: 8027
Loc: Buffalo NY, & Traveling the US...
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.
_________________________
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