Cleared Traditional

EyeQ nanoECP

K243014 · Eyeq, Inc. · Ophthalmic
Jun 2025
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K243014 is an FDA 510(k) clearance for the EyeQ nanoECP, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Eyeq, Inc. (Reno, US). The FDA issued a Cleared decision on June 18, 2025, 264 days after receiving the submission on September 27, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K243014 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date June 18, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390