510(k) K854471

PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T by Minnesota Laser Corp. — Product Code EWG

K854471 is an FDA 510(k) premarket notification submitted by Minnesota Laser Corp. for the device "PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T". The FDA issued a decision of Substantially Equivalent on February 13, 1986. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Minnesota Laser Corp. has at least 10 other 510(k) clearances on record.