Cleared Traditional

K032598 - SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

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

K032598 · Synergetics, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K032598

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
Combination Product No
PCCP Authorized No
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.

MPA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MPA Endoilluminator

All 40
Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K032598.
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
K062895 · Dutch Ophthalmic Research Center International BV · Oct 2006
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
K062259 · Iscience Surgical · Aug 2006
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
K041108 · Iscience Surgical Corporation · Jun 2004
INSIGHT 4000 ENDOSCOPE
K000252 · Insight Instruments Mfg., Inc. · Oct 2000
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
K000416 · Retinalabs.Com · May 2000
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
K980797 · Peregrine Surgical , Ltd. · May 1998
K032598 · SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
Download PDF FDA Summary Synergetics, Inc.