Cleared Abbreviated

HEINE OMEGA 500

K123316 · Heine Optotechnik GmbH & Co. KG · Ophthalmic
Feb 2013
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K123316 is an FDA 510(k) clearance for the HEINE OMEGA 500, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Heine Optotechnik GmbH & Co. KG (Herrsching, DE). The FDA issued a Cleared decision on February 26, 2013, 124 days after receiving the submission on October 25, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K123316 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2012
Decision Date February 26, 2013
Days to Decision 124 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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