Cleared Abbreviated

K123587 - HEINE MINI 3000 LED OPHTHALMOSCOPE

K123587 is an FDA 510(k) clearance for HEINE MINI 3000 LED OPHTHALMOSCOPE, manufactured by Heine Optotechnik GmbH & Co. KG. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Abbreviated 510(k) pathway after a 121-day FDA review.

K123587 · Heine Optotechnik GmbH & Co. KG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
121d
Days
Class 2
Risk

K123587 is an FDA 510(k) clearance for the HEINE MINI 3000 LED OPHTHALMOSCOPE. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Heine Optotechnik GmbH & Co. KG (Herrsching, DE). The FDA issued a Cleared decision on March 22, 2013 after a review of 121 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 - K123587

510(k) Number K123587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date March 22, 2013
Days to Decision 121 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
11d slower than avg
Panel avg: 110d · This submission: 121d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-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.
OLAF TEICHERT

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 - HLJ Ophthalmoscope, Battery-powered

All 29
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K123587.
HEINE MINI 3000(R) OPHTHALMOSCOPE
K131959 · Heine Optotechnik GmbH & Co. KG · Mar 2014
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K131961 · Heine Optotechnik GmbH & Co. KG · Dec 2013
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K032087 · Keeler Instruments, Inc. · Nov 2003
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K962767 · Alexander Mfg. Co. · Jul 1997