510(k) K841860

CO2 SURGICAL LASER SYSTEM XML-10 by Xanar, Inc. — Product Code EWG

K841860 is an FDA 510(k) premarket notification submitted by Xanar, Inc. for the device "CO2 SURGICAL LASER SYSTEM XML-10". The FDA issued a decision of Substantially Equivalent on November 8, 1984. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Xanar, Inc. has at least 10 other 510(k) clearances on record.