FDA Warns Quasar For Lack Of Proper Skin-Care Device Clearance; Firm Cites Mix-Up

摘要

FDA indicates it is taking a closer look at clearances and marketing claims for home-use skin-care devices with a Dec. 9 warning letter to Quasar Bio-Tech. In the letter, the agency focuses on Quasar's light emitting diode (LED) products and their 510(k) clearances and approved uses.