Laser comb and FDA report

[arya]

As a desperate guy I was thinking about giving hairmax laser comb a try, so I visited FDA site to read their report on the product, and bellow is the section that interest me.

“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 the 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 functioned as intended and the hair regrowth observed was
as expectedâ€￾

complete FDA summary http://www.fda.gov/cdrh/pdf6/K060305.pdf

my question is when FDA approve a product do they verify those study. If they do, don’t you think its worth a try?
Thank you

 

[$tackz]

I don't see how FDA approval honestly matters.

Things that aren't FDA approved frequently do work.

Things that are FDA "approved" (I use this term losely) alot of times do not work.

 

[Avery]

The FDA approves that it's safe to use, not that it'll work.

 

[$tackz]

The FDA approves that it's safe to use, not that it'll work.

That's only solidifies my point more... the FDA approves MANY things that are not safe to use.

Where are you going with this?

 

[Avery]

Uh, I was agreeing with you...

Just because the FDA approves it doesn't mean it's a well-made, effective product. It just means that it won't cause any additional effects other than what it warns against.

 

[$tackz]

sry wrong thread

 

[arya]

The problem is your focusing on the things in life that don't really matter. When I was a kid I had hopes and dreams. We all did. But over time, the daily grind gets in the way and you miss the things that really matter, even though they are right in front of you, staring you in the face. I think the next time you should ask yourself "Am I on the right track here?". I don't mean to be rude but people like you I really pity. So maybe you could use the few brain cells you have and take advantage of the knowledge I have given you now. Good luck.

i think we are all focusing in the same thing, thats why we are in same forum.

Anyway, coming back to the topic, I know FDA approval really doesn’t matter but from post I see its really matter for many.

The FDA approves that it's safe to use, not that it'll work.

May be I understood it wrong, but following part which is in in FDA summary report, is not verified ?

“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 the 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 functioned as intended and the hair regrowth observed was
as expectedâ€￾