The New Era of Device-Based Hair Restoration

Hair loss technologies are increasingly important tools used by dermatologists. Many patients seek treatment options that do not rely solely on medications or supplements, and optimizing outcomes often requires combining medical therapy with device-based technologies. Here, we provide an evidence-based overview of hair-oriented technologies available to dermatologists that have evolved over the past decade.

NONABLATIVE FRACTIONAL LASER THERAPY

It has been well-documented that lasers may stimulate hair growth. One example is the development of paradoxical hypertrichosis following laser hair removal procedures.^1–5 Fractional nonablative laser technology has been more recently reported within the medical literature as a treatment for hair loss.6

In 2024, the first Food and Drug Administration (FDA)–cleared laser technology (FoLix, Lumenis) became available for improving the appearance of scalp hair in adult men and women. This device, a 1565-nm nonablative fractional erbium-glass laser, was cleared for patients with Fitzpatrick skin types I through IV.^7,8 Nonablative fractional lasers create microscopic zones of thermal injury surrounded by unaffected tissue, producing a controlled wound-healing response while allowing rapid recovery.⁹

Clinical studies have demonstrated improvement in hair density, hair counts, and overall scalp hair appearance in patients with androgenetic alopecia.^10,11 More recently, a randomized investigator-blinded study comparing the 1565-nm nonablative fractional laser with 5% topical minoxidil reported significant improvements in total hair density, terminal hair density, and follicular unit characteristics after laser treatment.¹² Retrospective studies have also reported visible improvement with minimal discomfort, little to no downtime, and favorable tolerability.^7,13

In our clinics, 4 to 6 monthly sessions are typically required for initial optimal results. The treatment takes approximately 15 minutes. The hair is first parted, and the laser is then fired with associated contact cooling to minimize epidermal disruption. The hair must be dry during treatment. The treatments are quick and patients can return to work and normal activity immediately. This serves as an optimal device for people who cannot tolerate platelet-rich plasma, blood draw, medications, moderate pain, or transplant surgeries but still prefer procedural intervention.

Fractional lasers have also been investigated as a method of enhancing topical drug delivery. Laser-assisted delivery creates transient microscopic epidermal channels that may facilitate penetration of growth factors, peptides, and other scalp formulations.^14,15

Clinical studies using a 1927-nm thulium laser, fractional erbium-glass laser, and fractional CO₂ laser in combination with topical growth factor formulations have reported improvements in hair density, hair shaft diameter, and other hair growth parameters.^14–16 Although most studies have focused on androgenetic alopecia, isolated reports have also described improvement in alopecia areata.¹⁷ Larger randomized controlled studies with longer follow-up are needed to better define the long-term role of nonablative fractional lasers in hair restoration. Growth factor manufacturers should invest in well-designed rigorous clinical trials to document efficacy and safety.

PHOTOBIOMODULATION (LOW-LEVEL LIGHT THERAPY)

Photobiomodulation therapy (PBMT), also referred to as low-level light therapy, was first cleared by the FDA in 2007 for the treatment of androgenetic alopecia in both men and women.¹⁸ Since then, multiple randomized controlled trials have evaluated PBMT, making it one of the most extensively studied device-based treatments for hair loss.^19–25

PBMT uses red or near-infrared light to stimulate cellular activity.²⁶ The precise mechanism remains incompletely understood. It is thought that PBMT increases mitochondrial activity and adenosine triphosphate production, modulates transcription factors, prolongs the anagen phase, and promotes hair follicle proliferation.¹⁸ Most clinical studies have demonstrated improvement in hair growth with minimal adverse effects.^19,21–23

Various home-use and office-based PBMT devices are available (Table). Visible improvement generally requires several months of consistent treatment. In the author’s clinical experience, assessing the response requires 6 months. Reported adverse effects are uncommon and usually mild, including transient erythema, pruritus, tingling, dry skin, acneiform eruptions, and urticaria.¹⁹ Patients should avoid direct ocular exposure during treatment.

ULTRASOUND-ASSISTED GROWTH FACTOR DELIVERY

Ultrasound has recently gained interest as a method of enhancing transdermal delivery of topical agents.²⁷ Ultrasound technologies have both therapeutic and diagnostic applications in hair disorders.^28,29

Commercial systems (eg, Alma TED, Alma Lasers) have increased clinical interest in ultrasound-assisted delivery, although peer-reviewed clinical evidence remains limited. These systems use acoustic sound waves and air pressure to facilitate the delivery of proprietary scalp formulations without the use of needles.³⁰ Use of this device typically starts with a series of 3 or 4 treatments, scheduled 4 weeks apart, for 3 or 4 months, with maintenance depending on the patient’s response. This treatment is quick and associated with minimal discomfort.

Although ultrasound itself has not been FDA-cleared for hair growth, preclinical studies have demonstrated enhanced delivery of topical agents, such as finasteride and minoxidil.^31,32 Early clinical studies have also reported improvements in hair density and hair count with no reported pain or adverse events, particularly when ultrasound is combined with peptide-based formulation.²⁹

HIGH-FREQUENCY ULTRASOUND: A DIAGNOSTIC TOOL

High-frequency ultrasound has also emerged as a useful diagnostic tool in hair disorders. These devices provide noninvasive visualization of scalp structures and treatment-related changes.^28,33–36

A prospective study of 10 women with frontal fibrosing alopecia found that color Doppler ultrasonography demonstrated increased blood flow in the frontotemporal hairline as well as an association between forehead dermal thinning and absence of blood flow. These findings suggest that color Doppler ultrasonography may have potential as a noninvasive technique for assessing inflammation and dermal atrophy in frontal fibrosing alopecia.²⁸ Further studies are needed to validate its utility in disease monitoring. However, it appears promising as a research tool.

IONTOPHORESIS-BASED GROWTH FACTOR DELIVERY

Iontophoresis is an emerging low electrical current technology that clinicians have reported using for hair loss primarily in Europe and more recently in the United States. This novel device enhances transdermal drug delivery.^37,38 There are no FDA-cleared iontophoresis devices specifically indicated for the treatment of hair loss, and much of the available evidence remains preliminary or preclinical.^39–41

One clinical study evaluated iontophoresis-assisted delivery of growth factors in patients with androgenetic alopecia and telogen effluvium.⁴² Patients underwent 4 treatment sessions performed at 3-week intervals without anesthesia.⁴² Proposed mechanisms include enhanced transdermal delivery, increased microcirculation, stimulation of dermal repair pathways, promotion of angiogenesis, and growth factor release.^42,43

Although improvements in hair growth parameters were reported, statistical significance was not clearly described, limiting the interpretation of the findings.⁴² Larger controlled studies will be necessary to establish efficacy and define the role of iontophoresis in routine hair loss management.

HYDRADERMABRASION AND HYDRADERMABRASION-ASSISTED PRODUCT DELIVERY

Hydradermabrasion may involve the use of vortex-assisted or spinning fluid delivery, in which water is circulated within the device to cleanse and exfoliate the scalp. Topical agents such as salicylic acid, glycolic acid, lactic acid, or vitamin C may be incorporated into the treatment. Some commercially available systems incorporate proprietary peptide-containing formulations. For example, the HydraFacial platform includes the HydraScalp with Keravive scalp treatment, which is designed to improve scalp health.⁴⁴

A 2-patient case series of scalp psoriasis reported reductions in pruritus, scaling, and erythema following weekly hydradermabrasion with a diluted lactic acid solution for 2 to 3 weeks.⁴⁵ Although preliminary results are encouraging, published evidence remains limited, and additional studies are needed to define the efficacy and clinical role of hydradermabrasion in hair and scalp disorders.

PLATELET-RICH PLASMA

Platelet-rich plasma (PRP) has consistently trended positively in the literature, particularly for androgenetic alopecia. PRP is prepared from autologous whole blood using a single- or double-spin centrifugation system.⁴⁶ The platelet-poor portion is removed and the platelet-rich portion is then collected for injection. The mechanism remains unclear, but it has been proposed that these samples contain growth factors that stimulate hair growth.⁴⁶ PRP is not FDA-approved for hair loss.

In our clinical experience, injections are typically performed monthly for 3 to 4 months and then gradually spaced based on disease activity and clinical response. Androgenetic alopecia consistently has the strongest evidence supporting this treatment.⁴⁷ However, the authors have also found success using PRP for chronic telogen effluvium, scarring alopecias, and patients with concomitant hair loss disorders in which one component is androgenetic alopecia. With regard to sex differences, PRP appears to be effective in both men and women with androgenetic alopecia, although a meta-analysis found that hair density significantly increased only in men, whereas hair shaft diameter increased in both sexes.⁴⁸

The visit details are important to the overall patient experience. Candidates should be suitable for a blood draw, be well hydrated, and have a clean scalp before treatment. The procedure can be painful; topical lidocaine, injectable lidocaine, massage, and cooling devices (eg, Zimmer Cryo, Zimmer MedizinSystems) have all been used to help manage discomfort. Listening to music may help reduce procedural pain and anxiety.⁴⁹Shedding, bleeding, bruising, and headache are some of the most clinically relevant side effects in this author’s experience.

The injection plane remains variable across the field of dermatology, with some authors suggesting subcutaneous injection and others suggesting intradermal injection, at the level of the bulge.⁵⁰ Patients with early-stage disease who are able to return regularly for treatment tend to have the most favorable clinical outcomes.

MICRONEEDLING

Microneedling is not FDA-cleared for hair loss but has been used off-label. These minimally invasive treatments create controlled microchannels in the scalp using needle stamps, manual dermarollers, or automated microneedling pens. The devices are available for both in-office and home use. The proposed mechanisms include activation of the wound-healing cascade, stimulation of hair follicle stem cells, and enhanced transdermal delivery of topical agents, including minoxidil.^51,52

Clinical studies have reported improvements in hair density, hair count, hair thickness, and patient satisfaction, particularly when microneedling is combined with topical therapies.⁵² However, standardized treatment studies with uniform pressure, needle depth, number of passes, and treatment regimen are lacking. Some practitioners have suggested that overly aggressive microneedling can be harmful. “Tram-tracking”—a type of scarring—is a known complication.⁵³ Furthermore, at-home devices lack the ability for sterilization, raising safety concerns for those purchasing online.

Microneedles can assist with topical product delivery. Some authors have used microneedling to deliver minoxidil, finasteride, or exosomes.⁵⁴ Patients and clinicians should be aware that products that are not sterile or not intended for microneedling should be avoided, as granulomas are known complications. Within our clinics, we do not recommend at-home microneedling due to these risks.

Treatment intervals have varied across studies, with most protocols using treatments every 2 to 4 weeks. A 2025 review article noted that most trials showed improvement with microneedling plus minoxidil when compared with minoxidil alone; however, well-designed studies are lacking.⁵⁵ Another 2025 study reported that microneedling with topical minoxidil and finasteride improved hair density, hair diameter, and Norwood-Hamilton scores.⁵⁶

Microneedling appears to provide greater clinical benefit when combined with topical therapies, particularly minoxidil, than when used as monotherapy.⁵⁷ As an adjunctive procedure, it may be particularly useful for enhancing the delivery of topical agents, such as minoxidil and finasteride. Caution should be exercised when using compounded or nonsterile products. Clinicians should also recognize that enhanced transdermal drug delivery may increase the potential for local reactions and systemic absorption of topical medications.

CONCLUSION

Hair loss is a complex and multifactorial disorder that can substantially affect quality of life. Medical therapies remain the foundation of treatment; however, procedural therapies have become increasingly available as either primary or adjunctive treatment options. Moving into late 2026, clinicians need to be at the forefront of procedural hair loss treatment options, as they are the future of noninvasive hair loss management.

Disclosure: Dr. Farah was a co-investigator for Concert Pharmaceuticals, Intrepid Therapeutics, Incyte, Priovant, and Pfizer; serves as a consultant/advisory board member for Veradermics, Sun Pharma, and Lumenis Aesthetics; has received research support from Veradermics and L’Oréal; and has received honoraria from Veradermics, Sun Pharma, and Lumenis Aesthetics. She has also consulted for Rogaine. Dr. Fonseca has no conflicts to disclose. Generative artificial intelligence was used for grammar and readability.