510(k) K252120

Fundus On Phone Non Mydriatic (FOP NM-10) by Remidio Innovative Solutions Private Limited — Product Code HKI

K252120 is an FDA 510(k) premarket notification submitted by Remidio Innovative Solutions Private Limited for the device "Fundus On Phone Non Mydriatic (FOP NM-10)". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120.