Cleared Traditional

K151394 - Keeler Slit Lamp

K151394 is an FDA 510(k) clearance for Keeler Slit Lamp, manufactured by Keeler Limited. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K151394 · Keeler Limited · Ophthalmic device
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Sep 2015
Decision
107d
Days
Class 2
Risk

K151394 is an FDA 510(k) clearance for the Keeler Slit Lamp. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Keeler Limited (Windsor, GB). The FDA issued a Cleared decision on September 10, 2015 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Keeler Limited devices

FDA 510(k) Submission Details - K151394

510(k) Number K151394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date September 10, 2015
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 110d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 68
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K151394.
Portable Slit Lamp
K153545 · Shanghai Bolan Optical-Electric Co., Ltd. · Jun 2016
Z5 Slit lamp microscope, Z2 Slit lamp microscope
K152535 · Takagi Seiko Co., Ltd. · May 2016
Slit Lamp Microscope
K152429 · Shanghai Mediworks Precision Instruments Co. , Ltd. · May 2016
IOLMaster700
K143275 · Carl Zeiss Meditec, Inc. · Jul 2015
XCEL 455 SLIT LAMP
K141954 · Reichert, Inc. · Oct 2014
ZEISS CATARACT SUITE MARKERLESS
K141068 · Carl Zeiss Meditec, AG · Sep 2014