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

By Lauren Nardella / Email the Author / “The Rose Sheet” Jan. 9, 2012, Vol. 33, No. 2
Regulatory/Legislative / Word Count: 1292 / Article # 02120109006

Executive Summary

An FDA warning letter to Quasar Bio-Tech suggests the marketer of Baby Quasar and Quasar MD lacks correct 510(k) device clearance and is improperly marketing its home-use skin-care device products. Quasar maintains it holds the correct clearances, and that FDA may be confused by its product nomenclature.

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