Curewave Lasers Draws Warning Letter for Misbranding

The FDA issued Dallas-based Curewave Lasers a warning letter over its CureWave Laser, CureWave System and CureWave Medicore devices, deeming them adulterated and misbranded.

The agency found that the firm was marketing the products outside of the scope of a Class II exemption from 510(k) notification.  An agency inspection revealed that the firm was marketing the devices for tissue regeneration, healing and “improved vascular and cellular integrity.”

The products were also deemed adulterated because they were not manufactured in compliance with current good manufacturing practices.