510(k) K240615

Leos Laser and Endoscopy System by Beaver-Visitec International, Inc. — Product Code HQF

K240615 is an FDA 510(k) premarket notification submitted by Beaver-Visitec International, Inc. for the device "Leos Laser and Endoscopy System". The FDA issued a decision of Substantially Equivalent on April 3, 2025. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390.