Cleared Traditional

K951054 - XCEL SLIT LAMP

K951054 is an FDA 510(k) clearance for XCEL SLIT LAMP, manufactured by Leica, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K951054 · Leica, Inc. · Ophthalmic device
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Mar 1995
Decision
15d
Days
Class 2
Risk

K951054 is an FDA 510(k) clearance for the XCEL SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Leica, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 15 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Leica, Inc. devices

FDA 510(k) Submission Details - K951054

510(k) Number K951054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1995
Decision Date March 22, 1995
Days to Decision 15 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 110d · This submission: 15d
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 77
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K951054.
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K962532 · Expertech Assoc., Inc. · Jul 1996
NEITZ SLIT LAMP SL-H2
K951341 · Neitz Instruments Company, Ltd. · Jun 1995
NEITZ SLIT LAMP SL-H1
K951340 · Neitz Instruments Company, Ltd. · Apr 1995
SLIT LAMP, H-201
K936209 · Canon USA, Inc. · Apr 1994
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641 · Carl Zeiss, Inc. · Sep 1993
BURTON SLIT LAMP - MODEL 850
K924783 · R.H. Burton Co. · Apr 1993