510(k) K010716

VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB by Valmed Corp. — Product Code FSY

K010716 is an FDA 510(k) premarket notification submitted by Valmed Corp. for the device "VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB". The FDA issued a decision of Substantially Equivalent on May 30, 2001. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Valmed Corp. has at least 7 other 510(k) clearances on record.