Cleared Abbreviated

K123316 - HEINE OMEGA 500

K123316 is an FDA 510(k) clearance for HEINE OMEGA 500, manufactured by Heine Optotechnik GmbH & Co. KG. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Abbreviated 510(k) pathway after a 124-day FDA review.

K123316 · Heine Optotechnik GmbH & Co. KG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
124d
Days
Class 2
Risk

K123316 is an FDA 510(k) clearance for the HEINE OMEGA 500. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Heine Optotechnik GmbH & Co. KG (Herrsching, DE). The FDA issued a Cleared decision on February 26, 2013 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Heine Optotechnik GmbH & Co. KG devices

FDA 510(k) Submission Details - K123316

510(k) Number K123316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 110d · This submission: 124d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 Consultant

Tuv Sud America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HLI Ophthalmoscope, Ac-powered

All 70
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K123316.
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · Centervue S.P.A. · Apr 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939 · Amico Diagnostic Incorporated · Mar 2014
IVUE 500
K133892 · Optovue, Inc. · Mar 2014
IVUE WITH NORMATIVE DATABASE
K121739 · Optovue, Inc. · Jan 2013
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
K120057 · Bioptigen, Inc. · May 2012
RTVUE XR OCT
K120238 · Optovue, Inc. · Apr 2012