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Lunula Laser® – Onychomycosis
Lunula Laser® · Onychomycosis
Clear nail. No pills, no pain.
The first and only non-thermal laser FDA-cleared to increase clear nail growth in onychomycosis — 12-minute sessions, all five toes at once, no heat and no downtime.
The Lunula Laser brings new hope to people suffering from onychomycosis. Safe and effective, it is the first and only non-thermal laser FDA cleared for increasing new clear nail growth in individuals with onychomycosis. Lunula poses none of the risks and harmful side effects of oral anti-fungal medications and is painless, unlike thermal laser therapies. The laser light passes through the nail without damaging it or the surrounding skin, the in-office procedure takes minutes, and there is no recovery time — as few as four 12-minute sessions are needed to treat the affected area.
- 640 nm red + 405 nm violet
- Non-thermal
- 12-minute sessions
- All five toes at once
- FDA-cleared K153164
First and onlyLunula is the first and only non-thermal laser FDA cleared for increasing new clear nail growth in individuals with onychomycosis — no heat, no pain, no drug interactions.
6.1 mm
of new clear nail growth at six months in Erchonia’s FDA clinical trial
89%
of treated toenails grew clearer over six months — Zang et al., JCAD 2017
12 min
per session, all five toes treated at once — as few as four sessions
0
heat, pain, downtime or drug interactions
How it works
Two wavelengths. One target.
A patented red-and-violet pairing that reaches the fungus in and under the nail without touching the nail bed, toe or foot.
Lunula targets the fungus that lives in and under the toenail. Research proved the Lunula laser significantly increased clear nail over a six-month period: the laser targets the fungus and stimulates new clear nail growth. This patented red and violet laser delivers an innovative, multifaceted approach to low-level laser therapy — two wavelengths applied to the affected area at once. The 640 nm red diode drives the photochemistry that supports healthy nail growth, and the 405 nm violet diode brings its anti-microbial properties to the fungus itself. Lunula uses photonic energy to modulate cellular reactions that target the fungus, with no adverse reaction to the nail bed, toe or foot — and because it never heats, most patients feel nothing at all.
| Lunula Laser | What it means in the room | |
|---|---|---|
| Diodes | Two Class 2 line-generating diode modules, 640 nm red and 405 nm violet | Two mechanisms in one 12-minute session — nail growth and anti-microbial action |
| Tissue interaction | Non-thermal | No heat, no burning, no pain — no anesthetic and no cool-down |
| Coverage | Whole-foot chamber | All five toes treated at once; the light passes through the nail without damaging it |
| Protocol | 12 minutes weekly, as few as four sessions | Patients walk in, sit down and walk out — the staff-time cost is minutes |
“I have used many other toenail lasers in the past and I would have to say that this laser is the most effective and easiest laser for the patient and the doctor. The patients love the technology and love the fact that they are not feeling any discomfort when the laser is in use.” — Dr. Jordan Steinberg, DPM
Why clinics choose it
Why podiatrists choose Lunula
A cleared, drug-free answer to the most common complaint in the podiatry waiting room.
01
The only cleared non-thermal option
Oral anti-fungals carry liver risk and drug interactions; thermal lasers hurt. Lunula holds the category’s only non-thermal clearance for increasing clear nail — a treatment you can offer every patient, including the ones the alternatives exclude.
02
Twelve minutes, five toes
The whole foot goes into the chamber and the protocol runs itself. Four weekly sessions fit inside the visits you already book, with no consumables and no recovery time.
03
A rental program and a clear ROI
Lunula is available through a rental program — the practice rents the device rather than buying it, so there is no large capital outlay up front — and the financials are simple: a cash-pay service, minutes of staff time per session and a patient base that already has the condition. Ask our Lunula specialist for the numbers.
FDA indications for use
Indications for use (K153164)
The Lunula Laser™ device is indicated:
- For use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) (K153164)
Prescription use (21 CFR 801 Subpart D). Device intended for medical professionals. FDA 510(k) K153164.
Results
Measured in millimeters of clear nail.
The numbers behind the clearance — and the published follow-up.
6.1 mm
of new clear nail growth at six months
Erchonia’s FDA clinical trial for K153164; four 12-minute weekly sessions.
89%
of treated toenails showed an increase in clear nail over six months
Zang, Sullivan & Shanks, J Clin Aesthet Dermatol 2017;10(5):24–30 — retrospective analysis of three open-label studies, 50 great toenails; mean increase 5.18 mm.
67%
of toenails reached treatment success — 3 mm or more of new clear nail
Same paper. No adverse events were reported across the three studies.
Photos courtesy of Erchonia providers. Individual results may vary.
Specifications
Built for the podiatry room
The published specification.
| Configuration | 2 Class 2 line-generated laser diode modules |
| Wavelength | 640 nm & 405 nm |
| Modulation | Constant wave (CW) |
| Display | Full-color TFT touch-screen control center |
| Power source | 100–240 VAC, 50–60 Hz |
| Chassis | Powder-coated aircraft aluminum |
| Treatment area | 304 stainless steel for anti-microbial properties |
| Housing | Injection-molded, non-allergen material |
| Weight | 23 lb (10.43 kg) |
| Compliant to | ISO 13485 medical device quality · ISO 14971 risk management · IEC 60825-1 laser safety · IEC 60601-1 MEE safety · IEC 60601-1-2 EM |
Non-thermal
No heat. No pain. No downtime.
Where it works
Where Lunula works
A cash-pay service that fits the practices already seeing the patients.
01
Podiatry
Onychomycosis is one of the most common presentations in the podiatry office. Lunula gives you a cleared, drug-free answer for every one of them — including the patients who can’t take oral anti-fungals.
02
Dermatology and medical
A non-thermal, non-invasive protocol with no known side effects — the option to offer before a prescription, or when a prescription is off the table.
03
Aesthetic and med spa
Clear nails are an aesthetic outcome patients will pay for. Lunula runs alongside a contouring or skin program with minutes of staff time per session.
Clinic · Patients · P&L
See the numbers for your practice.
Project revenue impact, break-even timelines and per-visit value increases from your own clinic volume.
Increased visit value
Laser sessions integrate into care plans, increasing per-visit revenue without increasing provider strain.
Improved case acceptance
Patients commit to conservative plans more readily when non-invasive technology is included.
Retention and reactivation
A reason to return — and a reason to bring back the patients who drifted.
The line
Complete the podiatry room
Lunula for the nail; the pain-management line for the heel, the ankle and everything above it.
FX 635
Stand-mounted scanner · hands-free
The hands-free scanner platform, cleared for chronic low back pain and plantar fasciitis. Runs while you see the next patient.
EVRL
405 nm violet + 635 nm red · handheld
Red and violet in one instrument — the workhorse handheld with violet’s anti-microbial properties alongside its therapeutic role.
XLR8
Dual 635 nm red · handheld · entry level
The proven 635 nm foundation — two red diodes in a handheld built for the treatment room.
Next step
Bring Lunula to your practice.
A rental program is now available for the Lunula Laser. Tell us how your clinic runs and our Lunula specialist will walk you through the options — or download the Lunula financials first.
Every system ships with onboarding and protocol support from our clinical team.