Cleared Traditional

MAIA (AHMACME001)

K243504 · Centervue S.P.A. · Ophthalmic
Mar 2025
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K243504 is an FDA 510(k) clearance for the MAIA (AHMACME001), a Ophthalmoscope, Laser, Scanning (Class II — Special Controls, product code MYC), submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on March 17, 2025, 125 days after receiving the submission on November 12, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K243504 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date March 17, 2025
Days to Decision 125 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MYC — Ophthalmoscope, Laser, Scanning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570