Quasar Bio-Tech, Inc. – FDA Warning Letter, Feb 3, 2011

On December 9, 2011, the FDA issued a Warning Letter to Quasar Bio-Tech, Inc. dba Silver Bay LLC following an inspection from February 2-3, 2011. The inspection revealed that the firm was manufacturing and marketing LED products (Baby Quasar, Quasar MD21 Infrared Heat Lamp, and Quasar PowerPack) as medical devices without required marketing clearance or approval.

Specifically, the Baby Quasar, cleared as a prescription device for periorbital wrinkles at specific wavelengths, was being marketed for OTC use and new indications like anti-aging, acne, reducing pore size, and treating rosacea, blemishes, and sun damage, and with four wavelengths instead of the cleared two. The Quasar MD, cleared as a prescription device for temporary pain relief and increased local blood circulation, was marketed for OTC use and off-label indications such as collagen production and treating dermatologic conditions, claiming to be "3x more effective" than Baby Quasar for these uses. The Quasar Power Pack, combining Baby Quasar and Baby Blue, was marketed for use together for acne and blemishes without FDA clearance for combined use.

These changes in intended use and technology render the devices adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act, due to lack of PMA approval or IDE, and failure to submit new 510