510(k) K253822

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses by Zhuhai Fitlens Medical Technology Co., Ltd. — Product Code HQD

K253822 is an FDA 510(k) premarket notification submitted by Zhuhai Fitlens Medical Technology Co., Ltd. for the device "GPA (hexafocon A) Rigid Gas Permeable Contact Lenses". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916.