Risks and Side Effects
of Low Lever Laser Therapy (LLLT) or Cold Laser Therapy
Atre there safety issues
with regards to laser combs and other LLLT products
to treat hair loss?
Based on all available
evidence, there seems to be no safety issues with regards
to low level laser therapy products and devices. Although
some critics raise the caveat that long term issues
are not yet known, LLLT/cold-laser applications have
already been in use for more than 30 years with no report
of any serious safety issue.
About FDA approvals
for laser combs
FDA clearance is usually
not required for products that are intended for cosmetic
purposes. However, certain manufacturers make specific
claims that the laser comb (particularly Hairmax) would
promote hair growth in males with certain types of balding.
The company submitted
both safety and effectiveness data to obtain FDA clearance.
The effectiveness data was obtained from a multi-center,
randomized, placebo-controlled trial conducted at four
sites in the US. FDA "approval" requires a
much more stringent process.
Participants in the study
used a laer comb or a "sham" (placebo type)
device three times a week for 6 months. Based on this
limited scale study, FDA clearance was obtained.
The laser comb that that
I have used is based on the same principles as the tested
comb but with further improved safety power features.
the following links for more detailed information on
low level laser therapy for hair loss.