FDA 510 (K)

 GrivaMax™ Hair Growth System
FDA 510 (K) cleared for OTC sales in the United States

GrivaMax™ Hair Growth System – K171895

Our Grivamax™ low-level laser hair therapy device uses 272 red light diode lasers to promote hair growth, and has been awarded FDA 510 (K) clearance (K171895) following rigorous testing to prove substantial equivalency to an existing comparable laser cap that is legally marketed for the same purpose. Red light diode lasers (“low-level lasers”) are classified as a Class IIIa/ER laser system; a Medical Device that requires FDA clearance.

Intended Use / Indications for Use
The Grivamax™ Hair Growth System is indicated to promote hair growth in females with
androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have
Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Technological Characteristics
The Grivamax™ Hair Growth System consists of 272 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax™ Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.

Safety Warning:

While most hair regrowth laser caps on the internet look similar, understand that many are not FDA proven safe and effective. Less expensive, similar looking caps have not been tested for safety or efficacy and are being sold unlawfully.

Beware of businesses or sellers on legitimate-looking websites or other sites such as EBay and Amazon that either claim low-level laser therapy does not require FDA clearance, or those that do not (or will not) provide an FDA 510 (K) number.

For your safety and to sell these products lawfully, FDA testing and clearance is required. Only sites that provide or display a FDA 510 (K) number are legally cleared to sell low-level laser hair growth products in the United States.

Red light diode lasers (“low-level lasers”) used to promote hair growth are considered a medical device under U.S. Food & Drug Administration standards, and require rigorous testing to ensure consumer safety and efficacy. Please search the US FDA 510 (K) Database before considering other similar products.

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    GRIVAMAX LASER CAP 148

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