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NEWS : FDA Approves a Home Use Wrinkle Removal Laser Device

 
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davpet



Joined: 28 May 2006
Posts: 83

PostPosted: Mon Jul 20, 2009 2:16 pm    Post subject: NEWS : FDA Approves a Home Use Wrinkle Removal Laser Device Reply with quote

finance.yahoo.com/news/Palomar-Receives-FDA-prnews-3875123975.html?x=0&.v=1

"BURLINGTON, Mass., June 5 /PRNewswire-FirstCall/ -- Palomar Medical Technologies Inc. (Nasdaq: PMTI - News), 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."
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orangehrzn



Joined: 23 Feb 2005
Posts: 1044

PostPosted: Fri Jul 24, 2009 1:10 pm    Post subject: Reply with quote

Clearance from FDA does NOT mean the device is effective, just means it is safe to use in analogy to other similar devices.

I'm sure it won't remove a single wrinkle, it's just another gadjet with which to 'tap into' the consumer pocket.
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davpet



Joined: 28 May 2006
Posts: 83

PostPosted: Fri Aug 07, 2009 7:42 am    Post subject: Reply with quote

orangehrzn wrote:
Clearance from FDA does NOT mean the device is effective, just means it is safe to use in analogy to other similar devices.

I'm sure it won't remove a single wrinkle, it's just another gadjet with which to 'tap into' the consumer pocket.


Orangehrzn, I was actually waiting for your cynical response.

Look, of course it won't a hand held CO2 laser, and the only people who would be naive enough to believe it could erase wrinkles would be some gullible housewives.

Palomar and Johnson & Johnson are not some fly-by-night companies looking to make a quick buck. I'm sure they've spent millions of dollars developing and testing this product, so it will definitely have some clinical effect.

It may not erase wrinkles but it will certainly boost collagen, and that means it will find an important place in the anti-aging armory, especially if it's non-invase and non-irritating.
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orangehrzn



Joined: 23 Feb 2005
Posts: 1044

PostPosted: Fri Aug 07, 2009 3:59 pm    Post subject: Reply with quote

And do you know what the typical plastic surgeons 'cynical response' is at conferences when an LED 'rejuvenation' device is presented?

"I can't figure out which pic is 'before' and which 'after' .... " LOL

When I researched articles before my 'cynical response' was formed I saw this article that claimed reduction of pore size with LED. Well guess what .... I couldn't tell which pic is before and which after LOL

And please don't call people cynical because they don't subscribe to your naive point of view. When you send a couple of thousand $$$ down the drain for such FDA approved devices/procedures with minimal results, instead of spending a nice vacation in Europe, maybe you will appreciate more my 'cynical response' which is based on direct personal experience and analysis of published 'research'.
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davpet



Joined: 28 May 2006
Posts: 83

PostPosted: Sat Aug 08, 2009 1:38 am    Post subject: Reply with quote

Orangehrzn, I thought of you when i saw this clip : youtube.com/watch?v=6pUSIjdvTIY

Hello McFly, this a laser not an LED.
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orangehrzn



Joined: 23 Feb 2005
Posts: 1044

PostPosted: Sat Aug 08, 2009 2:25 pm    Post subject: Reply with quote

This is device with laser diodes. The only difference between these and the usual cheap LED's is that the light is coherent vs. incoherent something that your skin does not care about at all.

Of course calling it the fancy term "laser" instantly grabs the attention of people without sufficient background which think they will get at least partially the benefits of a CO2 skin resurfacing in their own kitchens.

This is one of the gazillion similar devices cleared by FDA in the past neither of which caused a revolition in skin rejuvenation. FDA will approve anything that is not harmfull they simply do not want to styfle the market - no wonder the USA market is full of gadgets that simply don't work ...
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davpet



Joined: 28 May 2006
Posts: 83

PostPosted: Tue Aug 11, 2009 4:15 am    Post subject: Reply with quote

orangehrzn wrote:
And do you know what the typical plastic surgeons 'cynical response' is at conferences when an LED 'rejuvenation' device is presented?

"I can't figure out which pic is 'before' and which 'after' .... " LOL

When I researched articles before my 'cynical response' was formed I saw this article that claimed reduction of pore size with LED. Well guess what .... I couldn't tell which pic is before and which after LOL


With regards to LED devices, you're absolutely right. Have a look at these before and after pics, it's next to impossible to tell the before from the after pic ...not.

phototherapeutics.com/pdf/photos-before-after.pdf


Last edited by davpet on Tue Aug 11, 2009 6:19 am; edited 1 time in total
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davpet



Joined: 28 May 2006
Posts: 83

PostPosted: Tue Aug 11, 2009 6:18 am    Post subject: Reply with quote

orangehrzn wrote:
Clearance from FDA does NOT mean the device is effective, just means it is safe to use in analogy to other similar devices.


Yes it does.

For FDA approval, you have to prove safety AND clinical efficacy.
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orangehrzn



Joined: 23 Feb 2005
Posts: 1044

PostPosted: Tue Aug 11, 2009 11:53 pm    Post subject: Reply with quote

Wow ... Palomar made a home device that erases wrinkles, releases it for couple of hundreds and looses hudreds of thousands cause plastic surgeons don't need its lasers anymore for the same purpose ....

Impressive example of altruism during bad economy LOL
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davpet



Joined: 28 May 2006
Posts: 83

PostPosted: Wed Aug 12, 2009 2:44 am    Post subject: Reply with quote

orangehrzn wrote:
Wow ... Palomar made a home device that erases wrinkles, releases it for couple of hundreds and looses hudreds of thousands cause plastic surgeons don't need its lasers anymore for the same purpose ....


Ahhh the cynicism.

Palomar has made a home device that will soften fine lines, so as to tap into the "multi-billion dollar consumer skin care market".

It will be used as an adjunct to in-office laser/light procedures, so it won't threaten their physician based products.
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orangehrzn



Joined: 23 Feb 2005
Posts: 1044

PostPosted: Thu Aug 13, 2009 11:33 am    Post subject: Reply with quote

Palomar are surely ready to tap into YOUR pocket not mine. The results of Omnilux that you took as 'evidence' above are less than impressive outside of their advertisement broshure, same thing with Matrixyl - stellar results on manifacturers broshure but somehow reviews that Matrixyl erased wrinkles are missing, I wonder why .... On the other hand reviews that Retin-A erased faint lines are not lacking at all .... Moreover, the Palomar home gadget (which is just 1000th gadget with same characteristics that passed FDA) will have at most 1/10th of the intensity of Omnilux devices, good luck achieving even the mediocre Omnilux results with that.

Let me know when you soften/erase a single wrinkle with it LOL
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Discohouse



Joined: 18 Oct 2006
Posts: 74

PostPosted: Wed Mar 25, 2015 1:39 pm    Post subject: Re: Palomar Reply with quote

pandagirl009 wrote:
The power of the energy behind an at home product does not compare to what the doctors offer at the office. This may provide a temporary fix buy cannot reach the power and therefore the effectiveness over time of the procedures the doctors offer. You cannot allow an unlicensed person to have such a strong device at home.

This is good if you have a dinner date or a week way and want to prepare - not for long term quality results.


orangehrzn said it right the first time; FDA clearance doesn't mean that the product is effective, but rather that it is safe.
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bohemianrox



Joined: 25 Aug 2015
Posts: 5

PostPosted: Tue Aug 25, 2015 8:46 pm    Post subject: Reply with quote

Many of the at home devices these days are amazingly effective. This would include laser, microcurrent, High Frequency, Radio Frequency, Dot Matrix..Led etc..
They can reduce sag and lift loose skin, diminish entirely or soften lines, even skin tone and texture, reduce the appearance of large pores and scars, alleviate hyperpigmentation and discolorations.
They may not be as strong as those at the Drs or a Salon but they can be used more frequently and a lot of money can be saved by DIY.
Are the results permanent? No.
Neither are they at a Drs office or the salon. Return visits are always a part of the plan.
Everything must be maintained.
You don't wash your hair once or clean your house and never have to do it again, do you?
You don't work out for a few months and expect the results to last forever..
And don't forget that any anti aging is not only reversing past damage but fighting future damage. That's quite a struggle. But these days it can be done.
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AdaBrown



Joined: 09 Sep 2015
Posts: 1

PostPosted: Wed Sep 09, 2015 10:02 pm    Post subject: Any side effect? Reply with quote

Using such devices would be very effective, but I was wondering is there any side effect as I used devices for removing black areas under my eyes but tiny fat practical appeared, then I stopped. I also know some lotion products, but as I'm working in a biochemistry BOC Sciences (bocsci.com), I know pretty clear about the side effects of the chemicals it contain. So I am looking for a device with the help of other lotion products.
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