510(k) K201623

LION Photocoagulator by Norlase Aps — Product Code HQF

K201623 is an FDA 510(k) premarket notification submitted by Norlase Aps for the device "LION Photocoagulator". The FDA issued a decision of Substantially Equivalent on August 11, 2020. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Norlase Aps has at least 2 other 510(k) clearances on record.