About This 510(k) Submission
K251336 is an FDA 510(k) clearance for the VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA), a Confocal Optical Imaging (Class II — Special Controls, product code OWN), submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 12, 2025, 196 days after receiving the submission on April 30, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.