510(k) K230965

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens by Acuity Polymers, Inc. — Product Code HQD

K230965 is an FDA 510(k) premarket notification submitted by Acuity Polymers, Inc. for the device "Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens". The FDA issued a decision of Substantially Equivalent on June 16, 2023. 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.