510(k) K252348

Tomey Optical Biometer OA-2000 (OA-2000) by Tomey Corporation — Product Code MXK

K252348 is an FDA 510(k) premarket notification submitted by Tomey Corporation for the device "Tomey Optical Biometer OA-2000 (OA-2000)". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Tomey Corporation has at least 4 other 510(k) clearances on record.