Cleared Abbreviated

K131589 - KEELER SLIT LAMP H-SERIES (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K131589 · Keeler, Ltd. · Ophthalmic device
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Jun 2013
Decision
27d
Days
Class 2
Risk

K131589 is an FDA 510(k) clearance for the KEELER SLIT LAMP H-SERIES. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Keeler, Ltd. (Windsor, Berkshire, GB). The FDA issued a Cleared decision on June 27, 2013 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Keeler, Ltd. devices

Submission Details

510(k) Number K131589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2013
Decision Date June 27, 2013
Days to Decision 27 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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.