Cleared Traditional

K930438 - MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS

K930438 is an FDA 510(k) clearance for MARCO MODELS G, manufactured by Marco Ophthalmic, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K930438 · Marco Ophthalmic, Inc. · Ophthalmic device
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Aug 1993
Decision
195d
Days
Class 2
Risk

K930438 is an FDA 510(k) clearance for the MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 195 days - an extended review 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: 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 Marco Ophthalmic, Inc. devices

FDA 510(k) Submission Details - K930438

510(k) Number K930438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date August 09, 1993
Days to Decision 195 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
85d slower than avg
Panel avg: 110d · This submission: 195d
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 78
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K930438.
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
BURTON HAND HELD SLIT LAMP - MODEL SL750
K924770 · R.H. Burton Co. · Jan 1993
BURTON SLIT LAMP - MODEL 2000
K924782 · R.H. Burton Co. · Jan 1993