510(k) K121187

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

K121187 is an FDA 510(k) premarket notification submitted by Katalyst Surgical, LLC for the device "KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES". The FDA issued a decision of Substantially Equivalent on September 17, 2012. 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.