Cleared Traditional

K132667 - SYNERGY ODM (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132667 · Topcon Medical Systems, Inc. · Ophthalmic device
Oct 2013
Decision
43d
Days
Class 2
Risk

K132667 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. (North Reading, US). The FDA issued a Cleared decision on October 9, 2013 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K132667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2013
Decision Date October 09, 2013
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 156d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.