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Palo Via At Home Wrinkle Removal Laser!
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caboodle
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Fri Jun 05, 2009 11:23 am      Reply with quote
The FDA just approved an "eye wrinkle-removal laser device for home use" made by Palomar Medical Technologies.

Shock Very Happy

Article at the Wall Street Journal:
Palomar Shares Soar After FDA OK's Home Wrinkle-Removal Laser
bethany
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Fri Jun 05, 2009 11:27 pm      Reply with quote
Very interesting article..thanks for posting! Of course what really remains to be seen is the impact of using lasers longer term.

After having 5 Fraxel treatments (a waste of $$$ for me), I can't really say that I would jump on this bandwagon immediately. But I never say never!! Very Happy

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Sat Jun 06, 2009 4:17 am      Reply with quote
Here's the article in full from this website:
http://www.skincareblog.net/2009/06/05/palomar-at-home-use-wrinkle-removal-laser-device/

Palomar Medical Technologies Inc., a leading researcher and developer of light-based systems for cosmetic treatments, today announced that it has become the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, laser device for the treatment of periorbital wrinkles. OTC clearance allows the device to be marketed and sold directly to consumers without a prescription.

This consumer device was developed by Palomar and completed together with Johnson and Johnson Consumer Companies, Inc., under a previously announced agreement to develop light-based anti-aging devices. Designed specifically for use in the home and based on years of research and clinical testing, this consumer device represents a major breakthrough in the aesthetic device industry.

Commenting on the achievement, Palomar Chief Executive Officer Joseph P. Caruso said, “This FDA clearance for a laser to treat wrinkles in the home opens up a tremendous opportunity to tap into the multi-billion dollar consumer skin care market with our patented technology. The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors’ office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost. This latest clearance further validates Palomar’s investment in research and development in the field of light-based anti-aging treatments and adds to the list of distinctions for Palomar as a technology leader in our industry.”

Mr. Caruso continued, “Years ago, we believed that light-based anti-aging applications could be brought to the home. We invested significant resources in research, development, clinical testing, and patent protection to make this a reality and ensure that Palomar would be the leader with this innovative technology. We envision a strong market for this OTC device and an increase in consumer awareness to help drive growth in our professional business.”

For more information on Palomar and its products, visit Palomar’s website at
www.palomarmedical.com.

You'll be one of the first to buy it Bethany! - and I won't be far behind! Laughing

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Mon Jan 25, 2010 12:05 pm      Reply with quote
I emailed Palomar to see how soon we would be seeing this product on the market. This is the response. (I received an OK from them to post the email). Their response also includes a hair removal device.

Thank you for your interest in Palomar.

In addition to our current suite of laser and pulsed-light systems for the professional setting, Palomar plans to commercialize a home-use, light-based device for the treatment of periorbital wrinkles. In June 2009, the device obtained FDA over-the-counter (OTC) clearance. Decisions regarding specific timing, distribution and cost for this consumer product have not yet been finalized. However, we expect to launch our product sometime during the second half of 2010. We plan to market our consumer product through specialty channels such as physician offices, high-end retailers or possibly internet sales directly through Palomar.

Palomar also signed a License Agreement with Proctor & Gamble to commercialize a patented home-use, light-based hair removal device for women. The device obtained FDA clearance in December 2006. In order to achieve FDA clearance, numerous studies with over 600 subjects and thousands of treatments were conducted. These studies demonstrated that, when used as directed, the light-based device created under this agreement delivers comfortable, effective, skin-safe hair removal. This device is not being sold as of yet and the treatment protocol would vary from the professional setting. The intent for this product is not to provide permanent hair removal as offered by our professional systems, but provide the "effect" of permanent hair removal as long as the user continues to use the device periodically. The benefits include the ability to use this device in the privacy of your own home and at a price accessible for the mass markets. Decisions regarding specific timing, distribution and cost for this consumer product are controlled by Proctor & Gamble and have not been publicly disclosed.

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kims
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Mon Jan 25, 2010 3:34 pm      Reply with quote
Does anyone know how much this will cost? Thanks!

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Mon Jan 25, 2010 4:18 pm      Reply with quote
Frodo wrote:
I emailed Palomar to see how soon we would be seeing this product on the market. This is the response. (I received an OK from them to post the email). Their response also includes a hair removal device.

Thank you for your interest in Palomar.

In addition to our current suite of laser and pulsed-light systems for the professional setting, Palomar plans to commercialize a home-use, light-based device for the treatment of periorbital wrinkles. In June 2009, the device obtained FDA over-the-counter (OTC) clearance. Decisions regarding specific timing, distribution and cost for this consumer product have not yet been finalized. However, we expect to launch our product sometime during the second half of 2010. We plan to market our consumer product through specialty channels such as physician offices, high-end retailers or possibly internet sales directly through Palomar.

Palomar also signed a License Agreement with Proctor & Gamble to commercialize a patented home-use, light-based hair removal device for women. The device obtained FDA clearance in December 2006. In order to achieve FDA clearance, numerous studies with over 600 subjects and thousands of treatments were conducted. These studies demonstrated that, when used as directed, the light-based device created under this agreement delivers comfortable, effective, skin-safe hair removal. This device is not being sold as of yet and the treatment protocol would vary from the professional setting. The intent for this product is not to provide permanent hair removal as offered by our professional systems, but provide the "effect" of permanent hair removal as long as the user continues to use the device periodically. The benefits include the ability to use this device in the privacy of your own home and at a price accessible for the mass markets. Decisions regarding specific timing, distribution and cost for this consumer product are controlled by Proctor & Gamble and have not been publicly disclosed.


Thanks for the update, Frodo. I will definitely be keeping my eye out for it!
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Mon Jan 25, 2010 4:31 pm      Reply with quote
kims wrote:
Does anyone know how much this will cost? Thanks!


See below

Decisions regarding specific timing, distribution and cost for this consumer product have not yet been finalized. However, we expect to launch our product sometime during the second half of 2010. We plan to market our consumer product through specialty channels such as physician offices, high-end retailers or possibly internet sales directly through Palomar.

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kims
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Mon Jan 25, 2010 5:42 pm      Reply with quote
Thanks, Frodo! I must've missed that part.

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Thu Jan 28, 2010 7:48 am      Reply with quote
I have spoken to the manufacturer today and asked them to send me us much information so I can post it to our topic.
No details as yet about price - spec, etc....

PQ

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Sun Nov 07, 2010 11:02 am      Reply with quote
Just saw an update in an aestheticians magazine, current issue:

Palomar delays home use device launch until Spring 2011 to incorporate use of a lotion (of course! LOL) and to build inventory.

It further states they need more time to prepare for their marketing, etc.

I wonder if med spas and derm offices are concerned that it will cut into their income....
it appears that Palomar expects there to be substantial demand.

BF
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Mon Nov 08, 2010 2:35 pm      Reply with quote
My reservation about this device revolves around the idea of it being home-use. Such a device must be extremely tame in order to it to be idiot proof enough that anyone without training can buy it off the shelf and use it at home. Consequently, will it really have any benefit at all? It can hardly be anywhere near the effectiveness of a clinic treatment that requires the operator to have specialist training to use it.

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Mon Nov 08, 2010 3:21 pm      Reply with quote
NotMeNotYou wrote:
My reservation about this device revolves around the idea of it being home-use. Such a device must be extremely tame in order to it to be idiot proof enough that anyone without training can buy it off the shelf and use it at home. Consequently, will it really have any benefit at all? It can hardly be anywhere near the effectiveness of a clinic treatment that requires the operator to have specialist training to use it.


I have never had any procedures done but I was thinking the same? How can it be both effective and safe????

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Mon Nov 08, 2010 5:32 pm      Reply with quote
DarkMoon wrote:
I have never had any procedures done but I was thinking the same? How can it be both effective and safe????


Home laser hair removal devices have become very popular. They seem to be effective - although I've never used one.

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Mon Nov 08, 2010 5:34 pm      Reply with quote
I will be buying it!!!!
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Mon Nov 08, 2010 6:02 pm      Reply with quote
Keliu wrote:
DarkMoon wrote:
I have never had any procedures done but I was thinking the same? How can it be both effective and safe????


Home laser hair removal devices have become very popular. They seem to be effective - although I've never used one.


Shows how little I know Laughing My concern would be the eyes, but I guess I am thinking conventional lasers not cosmetic. Embarassed

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Mon Dec 13, 2010 8:34 am      Reply with quote
Looks like QVC has it.

http://www.qvc.com/qic/qvcapp.aspx?view=2%26app=detail%26params=item^A212768

I can't get the link to work so after you go to QVC do a search for the item. A212768

http://www.trademarkia.com/palovia-85036879.html

Edited to add utube video

http://www.youtube.com/watch?v=tIW1XbejpjE

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Mon Dec 13, 2010 6:12 pm      Reply with quote
Frodo, the link should work now. Smile Thanks for the link too.
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Mon Dec 13, 2010 9:18 pm      Reply with quote
They ship this to Canada!! (some cosmetic items QVC ships here, some do not) Very Happy
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Mon Dec 13, 2010 9:47 pm      Reply with quote
havana8 wrote:
Frodo, the link should work now. Smile Thanks for the link too.


I did a copy and paste just like I always do but it won't work. Maybe someone else can try.

Ok guys, who is going to test this and get back to us?

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ShastaGirl
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Tue Dec 14, 2010 9:30 am      Reply with quote
Frodo wrote:
havana8 wrote:
Frodo, the link should work now. Smile Thanks for the link too.


I did a copy and paste just like I always do but it won't work. Maybe someone else can try.

Ok guys, who is going to test this and get back to us?


I can get to all 3 links by clicking on them. But I'm not quite ready to be the "product tester" on this one! Laughing Laughing

Looks like it's only advocated for use around the eyes.
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Tue Dec 14, 2010 10:07 am      Reply with quote
I would order one (advance order, ships 01/11/2011) but I'm on the fence because my eye area needs less help than my lower face.

Offhand I see several reasons that this is labeled for eye use only:
the device was tested on other facial lines and wrinkles and did not work because the strength of the laser is not sufficient to penetrate deeply enough on facial wrinkles.
there was not enough data on facial wrinkles for submission for approval to market from the FDA
they are working on another stronger device for facial wrinkles
the device was not tested on the face, which I find highly unlikely

What is interesting is that a search of the the QVC website for A212768 finds the device, whereas a search for PaloVia does not. Also interesting is that the Palo Via is not mentioned on Palomar's website under the site's New and Press Release sections. The only reference to it is in the Investor section:
http://phx.corporate-ir.net/phoenix.zhtml?c=96490&p=irol-newsArticle&ID=1506415&highlight=

I wish that I knew more about when this will air on QVC and how long the advance order price of $413.28, vs $500 will last. I think I will have to track down the FDA submission and clinical trial data.
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Tue Dec 14, 2010 10:10 am      Reply with quote
JonnyNJ wrote:
I would order one (advance order, ships 01/11/2011) but I'm on the fence because my eye area needs less help than my lower face.

Offhand I see several reasons that this is labeled for eye use only:
the device was tested on other facial lines and wrinkles and did not work because the strength of the laser is not sufficient to penetrate deeply enough on facial wrinkles.
there was not enough data on facial wrinkles for submission for approval to market from the FDA
they are working on another stronger device for facial wrinkles
the device was not tested on the face, which I find highly unlikely

What is interesting is that a search of the the QVC website for A212768 finds the device, whereas a search for PaloVia does not. Also interesting is that the Palo Via is not mentioned on Palomar's website under the site's New and Press Release sections. The only reference to it is in the Investor section:
http://phx.corporate-ir.net/phoenix.zhtml?c=96490&p=irol-newsArticle&ID=1506415&highlight=

I wish that I knew more about when this will air on QVC and how long the advance order price of $413.28, vs $500 will last. I think I will have to track down the FDA submission and clinical trial data.


I emailed QVC customer service last night asking when this would be on air. I will post that info when I get it.

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Tue Dec 14, 2010 10:10 am      Reply with quote
JonnyNJ wrote:
I think I will have to track down the FDA submission and clinical trial data.


Jonny, please let us know if you find any information on the clinical trial data!
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Tue Dec 14, 2010 1:03 pm      Reply with quote
rileygirl wrote:
JonnyNJ wrote:
I think I will have to track down the FDA submission and clinical trial data.


Jonny, please let us know if you find any information on the clinical trial data!


Good luck on finding any clinical trial data! I did manage to find this information about the FDA clearance:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=30364

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090525.pdf
(The predicate devices are an unusual choice!)

http://idc.api.edgar-online.com/efx_dll/edgarpro.dll?FetchFilingConvPDF1?SessionID=zYEHWoFEPY4bCIS&ID=6645201

As far as the "patent pending" mentioned in the article, it is impossible to figure out which one they are referring to. Palomar seems to lump together many devices in their patent applications for consumer home use. The applications are very vague and general and don't really mention the exact technology it will be using for the devices. No mention of any clinical trials either. You can look at this to get an idea of their patent application for a device "for use by a consumer in a non-medical and or non-professional setting":

http://www.freepatentsonline.com/y2008/0058783.html

I am not sure if this patent has anything to do with the LOI System, or even if the QVC PaloVia is related to the (then titled) LOI System. But it does appear that the Trademark for PaloVia Skin Renewing Laser is owned by Palomar:

http://tmportal.uspto.gov/external/PA_TOWUserInterface/OpenServletWindow?serialNumber=85103116&scanDate=2010081226832&DocDesc=Application&docType=APP&currentPage=1&rowNum=3&rowCount=4&formattedDate=09-Aug-2010

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Tue Dec 14, 2010 1:58 pm      Reply with quote
Here is this one Wellay personal skin laser. Not sure if this has been discussed here? I found it when i was doing a search for home lasers.
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