510(k) K242059

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) by X-Cel Specialty Contacts, A Walman Optical Company — Product Code LPL

K242059 is an FDA 510(k) premarket notification submitted by X-Cel Specialty Contacts, A Walman Optical Company for the device "Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.