Welcome to the Theradome™ as FDA Clears “Clinical Strength” Home Laser Hair Therapy Device

Theradome™ Inc has seen its LH80 laser helmet gain FDA’s clearance, bringing a so-called “clinical strength” therapy to the home for a fraction of the cost of visiting a hair restoration clinic.

Background

In the United States, roughly 80 million people suffer from hair loss due to androgenic alopecia, including approximately 40 million women. Traditionally, therapies for meaningful female hair growth have only been available in clinical settings and typically cost thousands of dollars. Less expensive, non-clinical options deliver much less therapeutic light (typically under 5 percent of a clinical option) than clinical devices and in most cases have not been cleared by the FDA. The Theradome™ brings clinical strength hair restoration therapy to the home at a fraction of the price, and it has been cleared for both safety and efficacy by the FDA.

The newly cleared LH80 laser helmet was designed by world leading experts in hair loss, dermatological health, and biomedical engineering. It is the first and only FDA Over-The-Counter cleared wearable laser treatment for use in the home.

According to the company press release, the device is clinically proven to grow hair in 98% of users with quoted statistics of 200% increase in hair thickness, volume and density within 6 weeks….enough to convince the FDA at least.

Physician comments

Sara Wasserbauer, M.D. and head surgeon at California Hair Restoration explains some key characteristics of a home use laser hair therapy device, “My advice to patients is to look for a device that is a laser, not an LED. Patients should also look for a device that is easy to use, like one that has hands free operation and a wavelength in the 670 nm range. This might seem like a technical detail, but according to the most recent scientific studies lasers in this wavelength are the ones that have proven effectiveness.” The Theradome™ has all these essential features and more.

Company comments

Tamim Hamid, founder and CEO of Theradome™, has personal experience with hair loss. “I had struggled with hair loss since I was thirty-two years old,” he says. “I come from a family of physicians, I tried all the latest prescription drugs, but none of them worked for me. As a NASA scientist and with my doctoral work in biomedical engineering, I knew there had to be a better solution. So I began working on a way to get rid of my medications and effectively regain my hair.”

Source: Theradome, Inc., Marketwire