510(k) K213880

Custom Stable Rigid Gas Permeable Scleral Contact Lens by Valley Contax, Inc. — Product Code HQD

K213880 is an FDA 510(k) premarket notification submitted by Valley Contax, Inc. for the device "Custom Stable Rigid Gas Permeable Scleral Contact Lens". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Valley Contax, Inc. has at least 2 other 510(k) clearances on record.