Cleared Traditional

SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

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

About This 510(k) Submission

K032598 is an FDA 510(k) clearance for the SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Synergetics, Inc. (St. Charles, US). The FDA issued a Cleared decision on November 24, 2003, 91 days after receiving the submission on August 25, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K032598 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MPA — Endoilluminator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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