510(k) K221263

Aqua Naina Plus Sterile Saline Solution by Chemtex USA, Inc. — Product Code LPN

K221263 is an FDA 510(k) premarket notification submitted by Chemtex USA, Inc. for the device "Aqua Naina Plus Sterile Saline Solution". The FDA issued a decision of Substantially Equivalent on October 12, 2022. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Chemtex USA, Inc. has at least 1 other 510(k) clearance on record.