Cleared Special

K232555 - Harmony (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232555 · Topcon Healthcare Solutions · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
89d
Days
Class 2
Risk

K232555 is an FDA 510(k) clearance for the Harmony. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Topcon Healthcare Solutions (Oakland, US). The FDA issued a Cleared decision on November 20, 2023 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Topcon Healthcare Solutions devices

Submission Details

510(k) Number K232555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Orasi Consulting, LLC
Lena Sattler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

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