LaserComb ... does it work?
- Thread starter mike1975
- Start date
ShedMaster
Senior Member
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- 5
It does work, you can comb your hair very well with the lasercomb. I just don't know what advantages it has over a conventional comb.
George Costanza
Established Member
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- 0
Here is anouncement that I pulled from the official hairmax lasercomb website in regards to the FDA clinical status.
Lexington International:
For the last 2 years Lexington has been focused on conducting scientific clinical trials and preparing a FDA 510K Submission. We are extremely excited about the potential of the LaserComb as our experience since the1980s has clearly demonstrated a very effective treatment for hair with a high degree of user satisfaction. Our company agenda is to qualify the HairMax LaserComb as an attractive, affordable and user friendly treatment.
We budgeted a significant amount of funds and proceeded as professionally as possible. We strategically pursued the following tasks.
-We hired a world authority on hair loss Dr. Martin Unger to coordinate the clinical trail
-We wrote a comprehensive trial Protocol and presented it to a research ethics committee known as an IRB (Institutional Review Board)
-We contracted with a leading laser research center with 2 clinical investigators.
-We hired a Biostatistician to design the statistical model.
-We hired an experienced FDA Consultant to communicate with the FDA and assist with our compliance
-We presented a Pre-Ide directly to the FDA for their comments and guidance.
-We finalized the 510k submission and had formal panel review.
FDA Clearance of New devices and new ‘indications of use’ is an in-depth process with many factors considered. Once the submission is lodged they have 90 days for their comments and every time they ask a question another 90 day clock begins. A 510K submission assumes that there are ‘predicate device’ and ours was submitted on the basis of there being substantial equivalence of other light based devices (non hair related) in the market.
At this stage the FDA has stated that they have not found other predicated devices cleared for 510k acceptance, they suggested that we need a ‘De Novo’ filing. They also requested a second phase study for OTC use from a further research site. It is common for the FDA to make this request especially for devices with new indications of use. This does not take away any merit of the strength and statistical significance of the clinical data we presented.
Since our clinical results were statically significant and superior to any other product on the market we thought we would have clearance on our first attempt.
We are continuing in our communications with the FDA to qualify each and every one of their requirements, beyond any reasonable doubt, and will continue and proceed with additional studies.
As we hope everyone could appreciate FDA approvals and device clearance take years and require extensive scientific data, comprehensive FDA compliance documents and regulatory advisors to present a strong submission. Most rulings are through a panel decision with some variables based on objective and subjective information.
As one of the Directors at Lexington International LLC, the developers of the LaserComb, who managed the process of the FDA submission I can state that we have great confidence in the HairMax LaserComb and the clinical results. We are continuing our scientific studies and submissions until we receive market clearance for medical regrowth claims.
I only wish the process was less cumbersome and the tasks for clearance easier to define. In the meantime we will find out what the legalities are of publishing the clinical data on this site.
Stay tuned……
Best regards,
David Michaels
Managing Director
Lexington International:
For the last 2 years Lexington has been focused on conducting scientific clinical trials and preparing a FDA 510K Submission. We are extremely excited about the potential of the LaserComb as our experience since the1980s has clearly demonstrated a very effective treatment for hair with a high degree of user satisfaction. Our company agenda is to qualify the HairMax LaserComb as an attractive, affordable and user friendly treatment.
We budgeted a significant amount of funds and proceeded as professionally as possible. We strategically pursued the following tasks.
-We hired a world authority on hair loss Dr. Martin Unger to coordinate the clinical trail
-We wrote a comprehensive trial Protocol and presented it to a research ethics committee known as an IRB (Institutional Review Board)
-We contracted with a leading laser research center with 2 clinical investigators.
-We hired a Biostatistician to design the statistical model.
-We hired an experienced FDA Consultant to communicate with the FDA and assist with our compliance
-We presented a Pre-Ide directly to the FDA for their comments and guidance.
-We finalized the 510k submission and had formal panel review.
FDA Clearance of New devices and new ‘indications of use’ is an in-depth process with many factors considered. Once the submission is lodged they have 90 days for their comments and every time they ask a question another 90 day clock begins. A 510K submission assumes that there are ‘predicate device’ and ours was submitted on the basis of there being substantial equivalence of other light based devices (non hair related) in the market.
At this stage the FDA has stated that they have not found other predicated devices cleared for 510k acceptance, they suggested that we need a ‘De Novo’ filing. They also requested a second phase study for OTC use from a further research site. It is common for the FDA to make this request especially for devices with new indications of use. This does not take away any merit of the strength and statistical significance of the clinical data we presented.
Since our clinical results were statically significant and superior to any other product on the market we thought we would have clearance on our first attempt.
We are continuing in our communications with the FDA to qualify each and every one of their requirements, beyond any reasonable doubt, and will continue and proceed with additional studies.
As we hope everyone could appreciate FDA approvals and device clearance take years and require extensive scientific data, comprehensive FDA compliance documents and regulatory advisors to present a strong submission. Most rulings are through a panel decision with some variables based on objective and subjective information.
As one of the Directors at Lexington International LLC, the developers of the LaserComb, who managed the process of the FDA submission I can state that we have great confidence in the HairMax LaserComb and the clinical results. We are continuing our scientific studies and submissions until we receive market clearance for medical regrowth claims.
I only wish the process was less cumbersome and the tasks for clearance easier to define. In the meantime we will find out what the legalities are of publishing the clinical data on this site.
Stay tuned……
Best regards,
David Michaels
Managing Director
George Costanza
Established Member
- Reaction score
- 0
Yea, I would love to see that clinical data on their website.
I think he's talking about the big 2. I believe I've read somewhere that they were expecting clinical results to be better than minoxidil, but that was before the trials began I think.
Healthy Nick
Established Member
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- 0
Well, it's got to do something. I mean, it's zapping the hell out of your follicles. :lol:
George Costanza
Established Member
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It's just hard for me to believe that they would have spent the money to enter the thing into the fda trials unless they were 100% positive that it was going to be approved. Unless they figured they could drag the trials on for years and make a bunch of $$$ selling to people like me who bought it just because they had the balls to put it through the fda trials.
BTW, has any other hairl oss product gone through the trials other then finasteride,minoxidil, and the LC? I'm curious.
BTW, has any other hairl oss product gone through the trials other then finasteride,minoxidil, and the LC? I'm curious.
Rubber Baby Buggy
Established Member
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I believe it helps just not as much as they were going on about.