That doesn't mean that they can't sell to other markets:
The FS-700 and FS-700PRO have already received U.S. Food and Drug Administration ("FDA") clearance. The FS-700PRO Thermometer is specifically designed for sale into the professional healthcare practitioner workplace including hospitals, clinics, physician offices, schools and government agencies and is currently being sold in Asia & Europe. A retail model is expected early in 2015 with more categories to follow.