Cleared Traditional

OcuMet Beacon (OCUB100)

K241931 · Ocusciences, Inc. · Ophthalmic
Apr 2025
Decision
295d
Days
Class 2
Risk

About This 510(k) Submission

K241931 is an FDA 510(k) clearance for the OcuMet Beacon (OCUB100), a Ophthalmoscope, Laser, Scanning (Class II — Special Controls, product code MYC), submitted by Ocusciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on April 22, 2025, 295 days after receiving the submission on July 1, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K241931 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date April 22, 2025
Days to Decision 295 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