510(k) K170335

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

K170335 is an FDA 510(k) premarket notification submitted by Valley Contax, Inc. for the device "Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens". The FDA issued a decision of Substantially Equivalent on March 24, 2017. 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.