510(k) K140362

KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES by Katalyst Surgical, LLC — Product Code HQF

K140362 is an FDA 510(k) premarket notification submitted by Katalyst Surgical, LLC for the device "KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES". The FDA issued a decision of Substantially Equivalent on September 15, 2014. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Katalyst Surgical, LLC has at least 6 other 510(k) clearances on record.