510(k) K833446

DOWNING SPECTRAL ILLUMINATOR by Vision Health Technology — Product Code HLX

K833446 is an FDA 510(k) premarket notification submitted by Vision Health Technology for the device "DOWNING SPECTRAL ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Vision Health Technology has at least 2 other 510(k) clearances on record.