Cleared Traditional

Fundus On Phone Non Mydriatic (FOP NM-10)

K252120 · Remidio Innovative Solutions Private Limited · Ophthalmic

Dec 2025

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K252120 is an FDA 510(k) clearance for the Fundus On Phone Non Mydriatic (FOP NM-10), a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Remidio Innovative Solutions Private Limited (Bengaluru, IN). The FDA issued a Cleared decision on December 12, 2025, 158 days after receiving the submission on July 7, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K252120 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2025
Decision Date	December 12, 2025
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF