Lumenis: LightSheer, AcuPulse & UltraPulse > Light Sheer Duet increases an unwanted chromophore: RED COLOR
Dr. Wiengart,
The best way to address this concern is by submitting it to the FDA via voluntary reporting form FDA 3500. Medical devices are a largely self-regulated field, and as the eyes and ears, and protectors of patients, it is our duty to report these concerns. The FDA will conduct an investigation when a concern is addressed, and manufacturers are either forced to explain, or correct the issue. This has the residual effect of keeping healthcare costs down, and malpractice complaints at a minimum.
If you burn, scar, or otherwise injure a patient, you should also report via mandatory form FDA 3500A. I have served as an expert witness in malpractice cases, and when interviewing with attorneys, I am often able to determine whether a settlement should be reached simply by asking if the practitioner submitted an FDA form 3500A, which most of you never do because you are not even aware of what it is. Submitting the form protects you, and forces the government to investigate the injury, which is almost always the result of some manufacturer defect, misbranding, unclear procedures, or non-disclosure of information pursuant to 21 CFR 1040.10-11. Protect yourself and protect your patients.
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149238.htm
Mickey Couvertier, CBET, CLRT
"(b)ecause of the absorption of photons".
Please elaborate on this. From what I understood already in high school, everything absorbs (or reflects or refracts) photons. It is off-the-cuff, uneducated remarks like this that are giving this field an image of being unprofessional, compared to other fields of medicine.
Kolmi
In my opinion, what makes the Duet the gold standard for hair removal. It is by far the best device on the market in terms of ease and consistency. I would not EVER doubt this device.
dng
Agree with dng. The machine doesn't break down, and the results are reliable. I would say that close to 95% of our patients are happy with the results.
Lily
Dear all Laser users,
I have been following the debate about Light Sheer Duet and I am as skeptic as many others about the low power. Today I watched the movie at Lumenis website:
http://www.aesthetic.lumenis.com/wt/page/duet_testimonials
and one thing that struck me was that the vacuum actually creates an unwanted chromophore when removing hair, THE RED COLOR. If you look closely you will see that when the handunit lifts of the skin the blood flow in the dermis is much higher than the untreated area.
We all know that RED is a bad chromophore in hair removal because of the absorption of photons. If they only use 12J/cm2 and some of the photons will be absorbed by this unwanted chromophore, I wonder how much energy passes through the RED color down into the dermis?
This new finding made me even more skeptical than before. Honestly I do not think this can work. I might be wrong but I will follow the development very closely during the next year. I would recommend all of you to do the same!