Cleared Special

Harmony

K232555 · Topcon Healthcare Solutions · Ophthalmic
Nov 2023
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K232555 is an FDA 510(k) clearance for the Harmony, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Topcon Healthcare Solutions (Oakland, US). The FDA issued a Cleared decision on November 20, 2023, 89 days after receiving the submission on August 23, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K232555 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2023
Decision Date November 20, 2023
Days to Decision 89 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050