Clinical evidence
Cleared, listed, and measured against clear nail growth
Onychomycosis treatments are easy to claim and hard to prove. Here is the regulatory position and the outcome data the manufacturer reports, stated plainly.
89%
of patients responded to treatment in reported trial data
6.1 mm
average new clear nail growth at six months
4 × 12 min
sessions in the standard treatment course
Before and after treatment
The measured endpoint is clear nail growth. These clinical photographs show an affected nail and the same nail after a course of treatment and regrowth. Individual results vary.
Before
After
Before
After
Before
AfterTreatment in the clinic
A short look at a session: the foot rests on the device, nothing touches the nail, and the laser runs for 12 minutes without a clinician in the room.
Regulatory status
The Lunula Laser is the first and only non-thermal laser FDA cleared for increasing clear nail growth in patients with onychomycosis, cleared under FDA 510(k) K153164. In Australia it is entered in the Australian Register of Therapeutic Goods under ARTG 386651.
Clearance relates to clear nail growth as the measured endpoint, not to eradication of infection or to a cosmetic guarantee.
How outcomes are measured
Trials in this field assess the change in area of clear nail from baseline, usually at three and six months, because the nail plate takes months to grow out. A patient is typically counted as a responder when clear nail area increases measurably against baseline.
Response also depends on the patient: severity of infection, nail thickness, blood supply, diabetes, footwear and reinfection risk all influence the result.
The research programme behind the device
Erchonia has investigated low-level laser therapy since 1996, taking the Lunula from in-vitro work through to in-vivo clinical trials before bringing it to market. Multiple method and device patents cover the approach, including US Patent 8,409,264 for fungal infection therapy using low-level laser.
European investigation
320 patients (2,320 toes) treated at 405 nm and 635 nm for twelve minutes, weekly, across four weeks.
United States submission
54 great toenails on the same four-week protocol. This dataset supported the 510(k) clearance: 67% of treated toenails met the individual success criterion, with average clear nail growth of 5.18 mm. No adverse events were recorded across the trials.
Mechanism of action
The device works photochemically rather than thermally — light modulates cell behaviour without heating, tingling or burning. The 405 nm violet wavelength drives production of reactive oxygen species with an antimicrobial effect, while 635 nm red supports nitric oxide generation, immune activity and vascularisation. Combined, they yield peroxynitrite, which is cytotoxic to fungal pathogens.
A rotating line-generated beam spreads the dose across the whole nail unit, so the plate, the bed and the germinal matrix are all treated regardless of where the pathogen sits.
Why not oral antifungals?
The toes are the body's most distal region, and limited blood flow often means poor drug delivery, non-response or recurrence. Because fungi are eukaryotes like our own cells, systemic antifungals can also disturb human biochemical pathways; hepatotoxicity, while rare, is documented, patients need routine liver function monitoring, and some cannot be prescribed them at all.
Webinar: improving clinical outcomes in onychomycosis using the Lunula Laser, with Dr Richard Silverstein.
Published studies and trial reports
The trial record behind the device, in date order. Documents are hosted by the manufacturer and distributor and open in a new tab.
- View paper
2011 · PDF
168-toe onychomycosis trial
Single weekly treatment protocol. Principal investigator: Dr Kerry Zang.
- View paper
2012 · PDF
105-patient great-toe evaluation, published in Mycoses
Twice-weekly treatment protocol. Principal investigator: Dr Kerry Zang.
- View paper
2013 · PDF
323-patient preliminary study (German edition)
Principal investigator: Robert Sullivan BSc (Hons) Podiatry, MSc Pod Surgery.
- View paper
2013 · PDF
48-week UK & Ireland paper, published in Aesthetische Dermatologie
Same cohort as the preliminary study, extended follow-up.
- View paper
2014 · DOC
76-week follow-up study
Long-term outcome reporting by Robert Sullivan.
- View paper
2015 · DOC
109-patient retrospective evaluation
Effect of the Erchonia Lunula on treating toenail onychomycosis.
- View paper
2015 · DOC
105-patient / 168-toe FDA-cleared study
Retrospective evaluation of the increase in clear nail; the submission behind FDA clearance.
Important disclaimer
Figures above are drawn from the manufacturer's published clinical data for the Erchonia Lunula Laser. They describe averages across study populations and are not a prediction of any individual result. Nothing on this page is medical advice — treatment suitability must be assessed by a qualified practitioner. We are happy to supply the underlying study references to clinicians on request.
Request the study referencesDownloads
Printable brochures for clinicians and patients.