Lumenis Launches Folix: An FDA-Cleared Fractional Laser For Hair Loss

Lumenis Be. Ltd, an energy-based medical device company specializing in aesthetic and eye care solutions, has introduced FoLix™, a fractional laser system for treating hair loss. Recently cleared by the FDA, FoLix is the first fractional laser to be cleared for hair loss treatment for both women and men in the United States.

What is the Difference Between FDA Cleared and FDA Approved?

According to a press release, FoLix has been cleared by the FDA for hair loss in both men and women. There is a notable difference between a product being FDA-cleared and FDA-approved. FoLix™ has been FDA-cleared, meaning it has undergone the FDA’s 510(k) clearance process for Class II medical devices. This is a less stringent regulatory pathway compared to full FDA approval. For 510(k) clearance, the manufacturer had to demonstrate that FoLix is substantially equivalent to another legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness. 

FDA clearance does not necessarily mean the device’s safety and efficacy have been reviewed as rigorously as an FDA-approved product. It simply means FoLix meets the criteria to be marketed as substantially equivalent to an existing legally marketed device for hair loss treatment.

What is FoLix™?

FoLix™ is a fractional laser pulse designed to stimulate hair follicles by leveraging the body’s natural processes. According to the Lumenis website, clinical studies have been conducted that have shown increased hair count, increased follicular units per cm2, and a noticeable improvement in scalp hair appearance. However, we have not found any published studies on this.

There is evidence that fractional laser therapy might improve hair loss for those with androgenic alopecia. Several studies have demonstrated the efficacy of different types of fractional lasers in improving hair loss outcomes. 

1. Fractional Nonablative Er Glass Laser: Studies have shown that this laser, operating at a wavelength of 1,550 nm, can induce hair growth in mice and humans. It has been used with topical finasteride and hair growth factors to treat recalcitrant androgenic alopecia.
2. Fractional Ablative CO2 Laser: This laser, operating at a wavelength of 10,600 nm, has been shown to induce the anagen phase and increase hair density and shaft diameter when used with topical growth factors. 
3. Fractional Nonablative Thulium Laser: This laser, operating at a wavelength of 1,927 nm, has also been shown to increase hair density and diameter when used with topical growth factors.

Side Effects

There are potential side effects associated with using fractional laser therapy, specifically FoLix™. Lumenis details these on their website, which include:

• Redness
• Swelling
• Scarring
• Pigmentation change

Its use is also not recommended for patients with any concurrent cancer or history of skin cancer, active infection, or fungal or bacterial diseases.

Reflections

The FDA clearance of FoLix represents a notable advancement in non-invasive hair loss treatments. However, it’s important to remember that clearance differs from full approval regarding regulatory rigor. As more clinical data becomes available, we look forward to further insights into this treatment’s efficacy and safety. 

Let us know what you think about this treatment and whether the potential benefits are worth the possible risks in the comments.