510(k) K041679

COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT by Onyx Medical, Inc. — Product Code ILY

K041679 is an FDA 510(k) premarket notification submitted by Onyx Medical, Inc. for the device "COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT". The FDA issued a decision of Substantially Equivalent on December 16, 2004. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Onyx Medical, Inc. has at least 10 other 510(k) clearances on record.