Cleared Traditional

Resolve Fundus Camera

K250683 · Optain Health, Inc. · Ophthalmic

Apr 2025

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K250683 is an FDA 510(k) clearance for the Resolve Fundus Camera, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Optain Health, Inc. (New York, US). The FDA issued a Cleared decision on April 30, 2025, 55 days after receiving the submission on March 6, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K250683 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2025
Decision Date	April 30, 2025
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF