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Old 18th December 2004, 06:21 PM   #21 (permalink)
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Ok , Just got off the phone with Barry Canter and he said that he is still trying to get this piece of equipment listed as a #1 class which would mean that anyone could use the machine. It looks like it will be a class 2 machine which means that a medical profession person would have to use the machine. Alex , the one thing that you wanted was faxed over and it didn't look right so Barry had someone look at it and they concurred and as it stands now it will listed as a class 2 machine. They are working with the FDA in trying to get it listed as a class 1 machine. Barry is going to Germany to meet with the owners of the machine.. They are afraid if they release the unit here that someone will try to duplicate it. I say that it would be financially impossible to do it

The machine will list for 24,995.00.. Still well below what most Class 2 lasers go for.. Most start at 40k
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Old 7th April 2005, 04:33 PM   #22 (permalink)
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I didn't see anything on their website...
Is there anything new on this?
Thanks,
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Old 22nd April 2005, 10:02 AM   #23 (permalink)
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Any new info?
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Old 22nd April 2005, 10:17 AM   #24 (permalink)
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This is not going to happen. In order for the machine to be truly affective and not be just a ho-hum gimmick, it would be classified as a class 2 medical device (I think it's 2) which means that it would have to be operated under the supervision of a medical practitioner. That would eliminate us as a market unless we want to hire an MD or a Nurse Practitioner to administer the treatments.
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Old 13th June 2005, 03:40 PM   #25 (permalink)
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Anything new?
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Old 27th June 2005, 03:36 PM   #26 (permalink)
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With today’s technology it is possible to have a class 1 laser and it work great. This is the case with our CMP unit. After a trip to Germany and hours with the FDA as of now it will be classed as a class one laser. But who knows with the FDA different day different person things change. But as of today the CMP Machine will be a class one laser. A few minor changes (not strength) have allowed the FDA to rule. We are very excited and will have more news later on when it will hit the market. Thanks to everyone for their interest and patience.
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Old 10th August 2005, 05:00 PM   #27 (permalink)
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The CMP machine will be at the ITA show in Nashville
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Old 10th August 2005, 05:49 PM   #28 (permalink)
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thanks hope to make show and will check it out.
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Old 10th August 2005, 06:39 PM   #29 (permalink)
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At what booth?
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Old 11th August 2005, 12:40 PM   #30 (permalink)
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did the FDA approval happen for a class 1?
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Old 4th September 2005, 04:26 PM   #31 (permalink)
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Any news? If it is a level 2, how hard is it to find the proper people to offer it at the salon level?
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Old 4th September 2005, 04:40 PM   #32 (permalink)
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I will call the dist of this machine and tell him to post on the machine
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Old 4th September 2005, 04:43 PM   #33 (permalink)
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I tried something yesterday, the doctor called it a IPL... and I know her laser cost her around 125k. Do you have to have a full MD to use a level 2 laser? She just got it and wanted to practice, of course I said YES!
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Old 6th September 2005, 12:26 AM   #34 (permalink)
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Quote:
I tried something yesterday
Having A problem with that 5 O'clock Shadow?
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Old 6th September 2005, 09:14 AM   #35 (permalink)
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no, no. an IPL is not for that...
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Old 6th September 2005, 02:54 PM   #36 (permalink)
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Our unit is nothing like a IPL unit, ours is a pulse laser. The FDA has not ruled on the class of our laser. The FDA has a self imposed time frame that will close out in 11 days. They have to give us an answer by then on which class laser our unit will fall.
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Old 7th September 2005, 11:12 AM   #37 (permalink)
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For questions on the CMP Smart Pulse laser, please call 704-532-9662
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