510(k) K172314

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) by Art Optical Contact Lens, Inc. — Product Code HQD

K172314 is an FDA 510(k) premarket notification submitted by Art Optical Contact Lens, Inc. for the device "Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)". The FDA issued a decision of Substantially Equivalent on September 20, 2017. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Art Optical Contact Lens, Inc. has at least 5 other 510(k) clearances on record.