Cleared Traditional

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

K113857 · Synergetics, Inc. · Ophthalmic
Apr 2012
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K113857 is an FDA 510(k) clearance for the SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on April 23, 2012, 115 days after receiving the submission on December 30, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number K113857 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2011
Decision Date April 23, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQB — Photocoagulator And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4690

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