Yes. Erchonia submitted the results of their successful clinical trial and the laser was granted market clearance by the FDA in June 2016 for the treatment of onychomycosis.
This device is unique in that it is the only true, dual diode, non-thermal, unattended Class 2 laser that offers multiple benefits. The Lunula combines the anti-fungal effects of the 405 nm wavelength with the regenerative outcomes of a 635 nm wavelength. The Lunula produces two wavelengths, 635 nm and 405 nm, both of which have been enriched by a proprietary rotating line-generated laser beam. The Lunula’s specially designed delivery mechanism maximizes both photon concentration and treatment surface area. The Lunula’s patented delivery system ensures that all infected tissue, nail bed and most importantly, the proximal germinal/matrix tissue are properly targeted and treated.
No. The higher wavelengths have less energy and normally more power is added which produces heat. Normally output power of watts and wavelengths of 900nm or higher are considered Class IV devices and produce an increase in temperature in the tissue being treated. The lower wavelength lasers, Class 2, Class 3A and 3B depending on power output, do not rely on heat production. Cold lasers initiate true physiologic responses, photo modulation. The Class2/3A/3B lasers have wavelengths 700 nm or lower.
The patient will feel no heat or any sensation from the laser.
No, the lower the wavelength, the greater energy produces and the greater antimicrobial/antifungal effect, high powered lasers work by boosting power to overcome the antimicrobial/antifungal but this can cause tissue destruction which is evidenced by the heat and smoke dangerous smoke plumes they produce.
The 635 nm wavelength stimulates endogenous mechanisms, which enhances the immunological function of resident neutrophil and macrophage function to further degrade the infectious agent. This wavelength also induces tissue rejuvenation, increased vascularization, which enables the dual diode approach to accelerate the growth of new clear nail growth. The 405 nm wavelength provides anti-microbial, antibacterial and anti-fungal effects. The patented dual diode approach provided by the Lunula Onychomycosis Device provides symbiotic wavelengths that enhance new clear nail growth at 6 months.
In the clinical trial results 89% of patients respond.
No complications were reported in all 4 LunulaLaser clinical trials.
During the Lunula clinical trial, a positive mycology study was received on all patients.
When using heat-based lasers to treat nail fungus, there are risks: thermal burning, necrosis, pain, threat of airborne mycosis with the potential of pulmonary ingestion with resultant longterm infection and disease. Both patients and medical staff can be at risk from exposure to laser plumes. When utilizing true cold laser therapy, such as the Lunula device, there is virtually no risk, either to the patient or the treating physician. The worst thing that can happen with true cold laser therapy for onychomycosis is nothing.
No. During the Lunula studies, no debridement was performed.
In the clinical trial, treatments consisted of 4 weekly 12 minute treatments.
• No chance of developing microbial resistance to this form of treatment
• Does not interfere nor interact with any systemic medicine
• No chance for liver toxicity
• Treatment protocol is painless, ensuring good patient compliance
• No pain during treatment
• No downtime
• Unattended treatment
Peroxynitrite is a compound that has potent anti-microbial effects. This compound is formed when Nitric Oxide (NO) reacts with Reactive Oxygen Species (ROS). The Lunula Laser by Erchonia, the only true Low Level Laser used to treat onychomycosis, uniquely has two different laser diodes; a 635nm and a 405nm. This combination of wavelengths is crucial in that the 635nm diode produces NO and the 405nm diode is the best producer of ROS, both within the visible light spectrum. Cell destruction is triggered by the cytotoxic effects of peroxynitrite. *NO + ROS = peroxynitrite destroys fungal pathogens* The 635nm laser enhances mitochondrial energy metabolism, which generates NO, and this is combined with the 405nm laser, which generates ROS, produces peroxynitrite. This byproduct is cytotoxic and destroys pathogenic bacteria, fungi and protozoa.
Yes, patients can become re-infected if they do not take precautions. If a spouse or significant other has clinical nail fungus, it is advised to not treat them without treating their partner. It is recommended for patients to take other precautions to prevent re-infection. Recommendations include, using a gas sterilizer to treat their shoes, using anti-fungal spray to use after wearing closed toe shoes and spray their showers with Tylex or other cleanser, all with the hope of preventing re-infection.
Clinical trial results proved and average of 6.1 mm New Clear Nail Growth at 6 Months.
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