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| | #21 (permalink) |
| Moderator | 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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| | #24 (permalink) |
| Moderator Join Date: Nov 2004 Posts: 94 | 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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| | #26 (permalink) |
| Rookie Join Date: Nov 2004 Posts: 19 | 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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| | #33 (permalink) |
| Hall of Famer Join Date: Jan 2005 Posts: 2,645 | 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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| | #36 (permalink) |
| Rookie Join Date: Nov 2004 Posts: 19 | 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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