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

This article was originally published in The Rose Sheet

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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