Lumenis, a global provider of energy-based medical devices, has received the Innovation Award in Hair Loss Technology category in the 2025 Medical Device Network Excellence Awards. This recognition highlights the company’s development of FoLix, the first and only FDA-cleared fractional laser specifically designed for hair loss treatment.
The Medical Device Network Excellence Awards honor the most significant achievements and innovations in the medical devices industry. Powered by GlobalData’s business intelligence, the Awards recognize the people and companies leading positive change and shaping the future of the industry.
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Lumenis won the award for introducing a novel, clinically validated technology that addresses significant gaps in current hair loss treatment solutions.
Meeting the unmet needs in hair toss treatment
Hair loss is a widespread condition, affecting more than 80 million people in the United States alone, according to the American Academy of Dermatology Association. The psychological and social impacts of hair loss are well-documented, with many individuals experiencing reduced self-esteem and quality of life. Despite the prevalence of the condition, existing treatment options have often fallen short—either due to limited efficacy, undesirable side effects, or the invasiveness of surgical procedures.
FoLix addresses this significant unmet need by providing a non-invasive, clinically validated alternative that is accessible to a broad demographic, including both men and women. Its ability to deliver measurable results without the drawbacks of traditional therapies positions it as a valuable addition to the hair loss treatments landscape. By focusing on safety, efficacy, and patient convenience, Lumenis has developed a solution that not only meets clinical needs but also aligns with patient preferences for minimally disruptive treatments.
The introduction of FoLix has the potential to improve the daily lives of millions of individuals affected by hair loss, offering a new pathway to hair loss treatment that is grounded in scientific evidence and designed for real-world use.
FDA-cleared fractional laser technology for addressing hair loss
Lumenis’ introduction of FoLix marks a pivotal advancement in hair loss technology. As the first and only FDA-cleared fractional laser for hair loss, FoLix fills a significant gap in the market for non-surgical, energy-based solutions. The device is built on Lumenis’ proprietary non-ablative fractional laser (NAFL) platform tailored specifically for stimulating hair follicles. Unlike traditional treatments that rely on pharmaceuticals, topical chemicals, or invasive surgical procedures, FoLix delivers precise pulses of laser energy to the scalp, leveraging the body’s natural healing processes to promote hair stimulation.
This innovation is underpinned by a unique mechanism of action: the creation of microscopic thermal zones (MTZs) in the skin, which trigger a regenerative response without damaging surrounding tissue. The technology’s specificity and safety profile are further validated by its FDA clearance, a milestone that sets a new industry standard for device-based hair loss treatment. By leveraging decades of expertise in energy-based medical devices, Lumenis has established a new category of treatment that is both effective and accessible.
Non-invasive, patient-centric hair loss solution
A key differentiator for FoLix is its focus on patient comfort and convenience. The treatment protocol requires only four to six monthly sessions, with each session being quick, at minimal discomfort, and requiring no downtime. This stands in stark contrast to many existing hair loss treatment options, such as surgical hair transplants, which can involve significant recovery periods, or topical and oral medications, which may have side effects or require daily use.
FoLix achieves this by incorporating an advanced algorithm that delivers laser micro-beams in a homogeneous, fractional pattern, ensuring optimal irradiance and uniform coverage in a single pass. These capabilities combined with its patent-pending FoliCool™ tip and intuitive user interface, minimize patient discomfort while maintaining fast, smooth, and effective treatment. Additionally, remote troubleshooting capabilities help maximize system uptime, supporting seamless integration into clinical workflows.
Patients benefit from a non-invasive, chemical-free, and surgery-free approach. The absence of anesthesia, needles, or post-treatment care makes FoLix particularly attractive to individuals seeking discreet and convenient solutions. This patient-centric approach not only broadens the appeal of hair loss treatments, but also encourages higher rates of treatment adherence and satisfaction.
Clinical evidence supporting safety and efficacy
The clinical validation of FoLix is a cornerstone of its recognition in the Innovation category. Preclinical studies, including animal models, have demonstrated that NAFL treatment induces a dose-dependent inflammatory response that stimulates hair follicle transition into a growth state. For example, in controlled studies on mice, NAFL treatment led to significant overexpression of key hair growth markers such as Sonic Hedgehog (HSS) and activation of the Wnt/B-catenin pathway, both of which are critical for hair follicle development and regeneration. Histological analysis confirmed positive tissue repair and hair follicle regeneration post-inflammatory response.
In clinical settings, retrospective studies involving human subjects have reinforced these findings. In a review of 98 patients aged 21-66, who underwent three to six FoLix treatments, independent board-certified dermatologists were able to correctly identify before-and-after images in 96.9% of cases. Both male and female subgroups demonstrated high rates of improvement, with no adverse events reported during or after treatment. Prospective studies further provided quantitative results that demonstrate an increase in hair count per square centimeter and an increase in the number of follicular units per square centimeter.
These outcomes provide strong evidence for both the safety and efficacy of FoLix, distinguishing it from many other hair loss technology modalities that may lack rigorous clinical backing or carry higher risks of side effects. The high safety profile and the statistically significant improvements in scalp hair appearance underscore the reliability of the technology for a broad patient population.
Strategic partnerships and market expansion
Lumenis’ ability to rapidly bring FoLix to market and achieve early adoption is the result of a robust network of partnerships with leading voices in the hair restoration and dermatology fields. Influential collaborators such as Dr. Neil Sadick, Dr. Mark Avram, and Dr. Ronda Farah have played a key role in validating the technology. Alongside these experts, Lumenis’ partnership with Bosley, the largest hair restoration practice in the United States, has enabled FoLix to be introduced to U.S. patients through a trusted and established provider. Bosley’s decision to offer FoLix reflects confidence in the technology’s potential to address a wide range of patient needs, accelerating its acceptance and credibility within the clinical community. Within less than a year of its U.S. launch, FoLix expanded into Canada, having received Health Canada clearance, and continued to build its global footprint.
“At Lumenis, we’re committed to developing cutting-edge solutions with real people in mind, treatments that deliver meaningful results while fitting seamlessly into everyday life. As the first and only FDA-cleared non-ablative fractional laser for hair loss, FoLix offers a safe, non-invasive option that helps patients regain confidence and feel their best.”
– Tzipi Ozer-Armon, CEO of Lumenis
Company Profile
Lumenis, an energy-based medical device company, is a global leader in developing best-in-class, innovative energy-based technology solutions for the aesthetic and eye-care industry. For decades, Lumenis has held its position as a market leader, innovator, and disrupter, responsible for revolutionizing existing treatment options and creating novel solutions for previously untreatable conditions. Lumenis is committed to advancing the frontiers of beauty and wellbeing, with ground-breaking solutions harnessing intense pulsed light (IPL), ablative lasers, CO2 treatments, long pulsed Nd:YAG, Q-Switched Nd:YAG, diode lasers, Radiofrequency (RF), RF micro-needling, dynamic muscle stimulation (DMS), and more. Redefining industry standards, Lumenis accelerates businesses and empowers individuals worldwide to embrace their best selves and live their best lives.
Contact Details
Erick Edwing, erick.edwing@havasred.com
Links:
Website: https://lumenis.com/aesthetics/products/folix/
