The PinPointe FootLaser was the first laser cleared by the FDA for the treatment of onychomycosis (toenail fungus). Companies which received their clearance by the FDA since have used the PinPointe device/clearance as their predicate. With this type of clearance, the other companies are only required to show “equivalency” to the PinPointe specifications.
PinPointe is the only laser on the market designed specifically for the treatment of onychomycosis. The other devices are modifications of an existing system used for different aesthetic procedures. Over 5 years was spent by PinPointe's research and development team to optimize the technology and protocol for only the treatment of onychomycosis. To date the PinPointe FootLaser has been performed on over 5 million toes.
An example of a company that used the PinPointe FootLaser FDA predicate is Cutera, which sells lasers to spas for aesthetic procedures. Although the clearance was for a 1.5 mm spot size, Cutera recommends the 5 mm spot size. This does not fall within the FDA approval and therefore they were required to create an adapter to reduce the spot size to 1.5 mm. Although they have this available, many physicians did not know there was this change and they are treating off-label with the 5 mm. larger spot sizes penetrate more deeply than PinPointe’s 1.5 mm spot size. Deeper penetration can cause damage to the nail and can also result in patient discomfort. In order to effectively target the condition, the fungus must be heated to 65°C for 7 seconds. In studies conducted by NuvoLase, PinPointe was the only laser capable to reach the target temperature as compared to long-pulsed Nd:YAG and Q-Switched lasers. We attribute this to the unique pulses stacking which allows practitioners to administer more energy (heat) per a pulse without harming the patient.