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FDA Approval

ViviComb's safety is based on thorough scientific research, thanks to which ViviComb received the approval of American Food & Drug Administration (FDA) twice.:

  • in June 2011 – the FDA approval to launch ViviComb on the market as the device supporting hair growth in women showing female pattern baldness,
  • in January 2007 - ViviComb became the first and only laser medical device that received the FDA approval for introducing the product to the market as the device treating hereditary hair loss in men.

FDA issued the approvals on the basis of clinical tests results. In both cases, these were six-month tests carried out in various medical centers; randomized clinical studies, which utilized placebo in the control group. For studies of 2011, the percentage of women who achieved a positive effect of the therapy was 100%. For 2007, 83% of men using ViviComb laser reported positive results. Both studies found no side effects.

These results provided conclusive evidence of high effectiveness and safety of ViviComb baldness treatment in both men and women.

Significance of FDA approvals

Many products introduced to the market promise high effectiveness of their anti hair loss treatment. However, the results are often disappointing. ViviComb definitely stands out from other anti hair loss products. A positive opinion issued by the FDA is the proof of quality and an indication of the device's lack of negative effects on health.

All clinical data submitted to FDA concerning ViviComb laser comb was subject to strict inspection and review prior to marketing authorization.

Moreover, obtaining FDA approval obliges to comply with stringent regulations and to maintain the highest standards, both at the production stage and at the later quality control.

ViviComb vs. other therapies

FDA approval obtained by ViviComb has a significant impact on the market of products inhibiting hair loss. Currently, there are only two other available anti hair loss treatments approved by the FDA. ViviComb is an alternative to them. Firstly, ViviComb therapy is an option for people wishing to avoid the use of drugs. Secondly, ViviComb is a substitute for topical treatment. So, no pills, no creams and no chemicals.

ViviComb is effective on its own, but of course it can be used in combination with other anti hair loss treatments. Its safety has been well documented and the device does not cause any side effects in people using it. Moreover, it is a one-time purchase that requires no extras to support it.