Cleared Traditional

Synergetics PHOTON EX

K143123 · Synergetics · Ophthalmic
Feb 2015
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K143123 is an FDA 510(k) clearance for the Synergetics PHOTON EX, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Synergetics (O' Fallon, US). The FDA issued a Cleared decision on February 24, 2015, 116 days after receiving the submission on October 31, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K143123 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2014
Decision Date February 24, 2015
Days to Decision 116 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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