FDA approval for lasercomb finally?????

[jh]

And there's a bit more info here, too:

http://news.hairlosshelp.com/fda-news/i ... lasercomb/

 

[HLTguest]

Take a look at this. PDF format.

http://www.fda.gov/cdrh/pdf6/K060305.pdf

Quote :
A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use de device three times per week on nonconcurring days for a total of 26 Weeks. Subjects in the lasercomb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the lasercomb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functionned as intended and the hair regrowth observed was as expected

end of quote.

Interesting. But what weight does this really have? Has Avacor also obtained FDA clearance? Or Procede?

 

[grabber]

Come on man, why be so negative. Avacor has NEVER ever been approved by FDA.

http://www.askdocweb.com/avacor.html

Quote:
If that wasn't enough, the FDA has banned the marketing of all over-the-counter hair-growth products, except those approved by the agency's New Drug Application process. Avacor has not passed this process, nor has it been approved by the FDA.

Take a look at this. PDF format.

http://www.fda.gov/cdrh/pdf6/K060305.pdf

Quote :
A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use de device three times per week on nonconcurring days for a total of 26 Weeks. Subjects in the lasercomb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the lasercomb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functionned as intended and the hair regrowth observed was as expected

end of quote.

Interesting. But what weight does this really have? Has Avacor also obtained FDA clearance? Or Procede?

 

[HLTguest]

Sorry, not trying to be negative. I am a newbie so when it comes to this stuff I get very confused.

Good links though, thankyou for them. I hope this product has some effectiveness to it.

 

[JayB]

Here are some pics. They must be too good to be true. I just can't believe them.

http://www.lasercomb.net/beforeafter.htm

lol these pictures are garbage...my gosh some of you will take any single solitary hair on your head that you can get. ALL those guys who were balding in the before pictures STILL look like they are balding in their after pictures...who is trying to kid who in these pictures?

5 hairs on an area where 10,000 should be is a cosmetic joke...desperate people on here seriously.

 

[HLTguest]

Here are some pics. They must be too good to be true. I just can't believe them.

http://www.lasercomb.net/beforeafter.htm

lol these pictures are garbage...my gosh some of you will take any single solitary hair on your head that you can get. ALL those guys who were balding in the before pictures STILL look like they are balding in their after pictures...who is trying to kid who in these pictures?

5 hairs on an area where 10,000 should be is a cosmetic joke...desperate people on here seriously.

About 2 of the pics are lacking. I think most show some improvement no matter how slight. To me, any regrowth, even the slightest is a plus because it shows that something is really happening. Just my opinion of course.