510(k) K230824

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) by Art Optical Contact Lens, Inc. — Product Code LPL

K230824 is an FDA 510(k) premarket notification submitted by Art Optical Contact Lens, Inc. for the device "IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)". The FDA issued a decision of Substantially Equivalent on September 6, 2023. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Art Optical Contact Lens, Inc. has at least 5 other 510(k) clearances on record.