510(k) K242393

Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses by Acuity Polymers, Inc. — Product Code HQD

K242393 is an FDA 510(k) premarket notification submitted by Acuity Polymers, Inc. for the device "Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Acuity Polymers, Inc. has at least 10 other 510(k) clearances on record.