FDA Warning letter to HairMax

[Vasilius]

The FDA has sent a warning letter to the company that produces the HairMax LaserComb.

 

Lexington Int., LLC, is marketing two newer models of their lasercomb, the HairMax Premium and SE models, as FDA-Approved. The only FDA-cleared model is their original model.

 

Also, they are marketing it for use by women. It is only FDA-cleared for treating hair loss for men with NW-IIa through NW-V category androgenetic alopecia.

 

Click the link below to view the FDA letter:

http://www.fda.gov/foi/warning_letters/s6948c.htm

 

-Vasilius

[Vasilius]

The FDA has sent a warning letter to the company that produces the HairMax LaserComb.

 

Lexington Int., LLC, is marketing two newer models of their lasercomb, the HairMax Premium and SE models, as FDA-Approved. The only FDA-cleared model is their original model.

 

Also, they are marketing it for use by women. It is only FDA-cleared for treating hair loss for men with NW-IIa through NW-V category androgenetic alopecia.

 

Click the link below to view the FDA letter:

http://www.fda.gov/foi/warning_letters/s6948c.htm

 

-Vasilius

[Bill - Seemiller]

Vasilius,

 

Thankis for the reminder about this.

 

For our hair loss blog on this, see "HairMax Lasercomb Makers Warned by the FDA about Illegal Sales of NonFDA Cleared Devices.

 

Does anyone have an update on whether or not this was actually resolved?

 

Best wishes,

 

Bill

[Vasilius]

Thanks Bill. Didn't mean to be redundant.

 

 

-V