510(k) K181579

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K by E&E Optics, Inc. — Product Code HQD

K181579 is an FDA 510(k) premarket notification submitted by E&E Optics, Inc. for the device "eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K". The FDA issued a decision of Substantially Equivalent on July 26, 2018. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916.