510(k) K081656

VISUALASE THERMAL THERAPY SYSTEM by Biotex, Inc. — Product Code LLZ

K081656 is an FDA 510(k) premarket notification submitted by Biotex, Inc. for the device "VISUALASE THERMAL THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 10, 2008. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Biotex, Inc. has at least 9 other 510(k) clearances on record.