Cleared Special

K151952 - Synergy ODM

K151952 is an FDA 510(k) clearance for Synergy ODM, manufactured by Topcon Medical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Special 510(k) pathway after a 78-day FDA review.

K151952 · Topcon Medical Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Oct 2015
Decision
78d
Days
Class 2
Risk

K151952 is an FDA 510(k) clearance for the Synergy ODM. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Topcon Medical Systems, Inc. (Oakland, US). The FDA issued a Cleared decision on October 1, 2015 after a review of 78 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 Medical Systems, Inc. devices

FDA 510(k) Submission Details - K151952

510(k) Number K151952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2015
Decision Date October 01, 2015
Days to Decision 78 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
32d faster than avg
Panel avg: 110d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

NFJ Device Classification - Class 2, Special Controls

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

O'Connell Regulatory Consultants, Inc.
Maureen O'Connell

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

All 47
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