Cleared Traditional

K032598 - SYNERGETICS SYNERLIGHT FIBER OPTIC LIGH...

K032598 is the FDA 510(k) clearance for SYNERGETICS SYNERLIGHT FIBER OPTIC LIGH... by Synergetics, Inc.. It is a Class 2 Ophthalmic device (product code MPA) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K032598 · Synergetics, Inc. · Ophthalmic device
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Nov 2003
Decision
91d
Days
Class 2
Risk

K032598 is an FDA 510(k) clearance for the SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Synergetics, Inc. (St. Charles, US). The FDA issued a Cleared decision on November 24, 2003 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synergetics, Inc. devices

Submission Details

510(k) Number K032598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date November 24, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.