Business Model

Regulatory Pathway

Our device is a class II medical device that irradiates a low frequency laser on the targeted area where the nasal septum is deviated. Class II medical device has a minimal risk to the patient. After the device is registered with FDA, we will prepare and submit our Premarket Notification (510(k)) notifying that there are existing predicate devices that can help ensure approval. Then we will collect data from clinical and product testing. Once FDA approved, our device will be commercially available.

Intellectual Property