Alopecia laser therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Ogechukwu Hannah Nnabude, MD

Overview

Laser therapy has thus far not proven to be of any benefit in the treatment of alopecia.

Laser Therapy

Low-level Laser Therapy

A low level laser is shone directly on the scalp to stimulate hair growth through "Photo-Biostimulation" of the hair follicles. One product of these low-level laser therapies is the "Hairmax Lasercomb". There is no peer-reviewed evidence to support this claim. There is some debate over the FDA's acknowledgment of the Lasercomb, but it has been accepted by the FDA as effective in the submitted claims.[1] The Lasercomb was cleared by the FDA as being Substantially Equivalent (SE) to predicate devices legally marketed before May 28, 1978. This clearance is not the same as approval because it only applies to the lasercomb and not to any other similar laser-based hair devices. The devices that the Lasercomb proved itself equivalent to were a variety of FDA approved laser based/non hair growth devices intended for hair removal and pain relief, and 2 non FDA approved non-laser based/hair growth devices such as the Raydo & Wonder Brush and the Vacuum Cap. These last two devices were sold in the early 1900's and are well established as medical quackery, but they were legal to market at the time which does satisfy the FDA's 510k SE criteria. The 510k number for the Lasercomb is K060305. The Leimo laser was recently approved by the TGA (Therapeutic Goods Administration) of Australia as a Class IIa Medical Device that regrows hair. Its ARTG number is 139 456.

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