510(k) K231011

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse by Meridian AG — Product Code HQF

K231011 is an FDA 510(k) premarket notification submitted by Meridian AG for the device "Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse". The FDA issued a decision of Substantially Equivalent on September 12, 2023. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Meridian AG has at least 5 other 510(k) clearances on record.