Cleared Traditional

K924782 - BURTON SLIT LAMP - MODEL 2000

K924782 is an FDA 510(k) clearance for BURTON SLIT LAMP - MODEL 2000, manufactured by R.H. Burton Co.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K924782 · R.H. Burton Co. · Ophthalmic device
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Jan 1993
Decision
126d
Days
Class 2
Risk

K924782 is an FDA 510(k) clearance for the BURTON SLIT LAMP - MODEL 2000. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 126 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 R.H. Burton Co. devices

FDA 510(k) Submission Details - K924782

510(k) Number K924782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date January 27, 1993
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
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 38
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K924782.
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
BURTON HAND HELD SLIT LAMP - MODEL SL750
K924770 · R.H. Burton Co. · Jan 1993
BURTON SLIT LAMP
K924787 · R.H. Burton Co. · Jan 1993
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
K910980 · Site Microsurgical Systems, Inc. · May 1991
WOODLYN SLIT LAMP MODEL HR-1
K900476 · Woodlyn, Inc. · Feb 1990