The CoolBreeze laser is a treatment for toenail fungus (onychomycosis) that uses infrared light to destroy the fungus in the nail bed. It is developed by the company CoolTouch, which markets its laser system for safe, effective, and quick treatment. 

How the treatment works

The CoolBreeze laser uses infrared light energy at specific wavelengths (1064nm and 1320nm) to heat and vaporize the fungus and bacteria within the nail bed, which causes toenail fungus. 

• Safety features: The system has a built-in temperature sensor that automatically shuts off the laser once the proper target temperature is reached to prevent overheating.
• Cooling spray: It also uses a cryogen spray to cool the nail, which adds to patient comfort and helps make the procedure virtually pain-free.
• Control: The Varia Breeze model offers an adjustable spot size, allowing a medical professional to customize the treatment based on the size of the infected nail. 

How it works

• Penetrates the nail: The laser's wavelength penetrates the toenail and surrounding skin to reach the fungus and bacteria within the nail bed.
• Vaporizes fungus: The laser energy vaporizes the destructive fungus that causes discoloration and other symptoms.
• Promotes new growth: The laser treatment can kill the fungus on contact, but it takes time for the healthy nail to grow out completely, which can take 6-12 months. 

The treatment process

• Preparation: Your nails will be cleaned and filed before the procedure begins.
• During the procedure: You will feel a warming sensation as the laser passes over the nail, immediately followed by a burst of cooling spray for comfort.
• Duration: The treatment is quick, typically taking about 15-30 minutes for both feet, depending on the number of toes.
• Frequency: Multiple sessions are often recommended for best results, usually 2-4 treatments spaced at least six weeks apart. 

Advantages

• No downtime: Patients can walk in and out, with no recovery time needed. Normal activities can be resumed immediately.
• Relatively painless: The combination of temperature monitoring and a cooling spray makes the treatment virtually pain-free, with a mild warming sensation being the most common experience.
• High success rate: Some studies show an 80–88% success rate in eliminating toenail fungus. This is potentially more effective than many topical creams (around 40%) and oral medications (around 60–70%), which also carry the risk of liver damage.
• Can be used with nail polish: Patients can apply nail polish or get pedicures right after the procedure.
• No side effects: According to CoolTouch, clinical studies on the laser have not shown any adverse reactions or known side effects. 

Disadvantages and considerations

• Not an instant fix: While the laser kills the fungus, the toenail needs time to grow out, which can take several months. New, clear growth will be visible near the cuticle in two to four months.
• Multiple sessions required: For best results, multiple treatments are recommended. Some facilities recommend 3 sessions spaced several weeks apart, while others suggest 5 or more.
• Does not prevent reinfection: Fungus is widespread in the environment. Post-treatment care is crucial, and facilities often recommend continued use of topical treatments and antifungal shoe spray to minimize the chance of reinfection.
• Cosmetic and not covered by insurance: Laser toenail treatments are generally considered a cosmetic procedure and are typically not covered by insurance. However, you may be able to use a Flexible Spending Account or Health Savings Account for payment. 

FDA clearance vs. approval

• It's important to understand the FDA's clearance process regarding this treatment: 
• Pending clearance: While some podiatry services state that the CoolBreeze is FDA cleared for toenail fungus.
• FDA approval for laser devices: There are no FDA-approved laser devices specifically for toenail fungus. The agency often provides 510(k) market clearance, which does not guarantee a device's safety or effectiveness for a specific use. The FDA's stance emphasizes "temporary increase in clear nail" rather than a complete cure. 

Before and after care

• Preparation: Patients should remove all nail polish, art, or oils from their toenails the day before the procedure. Some providers may also file down the infected nail to reduce its thickness.
• Aftercare: Your clinician will provide specific post-treatment instructions to help prevent reinfection. This often includes using a topical antifungal solution and shoe spray.