Cleared Traditional

K930442 - MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS

K930442 is an FDA 510(k) clearance for MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS, manufactured by Marco Ophthalmic, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K930442 · Marco Ophthalmic, Inc. · Ophthalmic device
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Aug 1993
Decision
195d
Days
Class 2
Risk

K930442 is an FDA 510(k) clearance for the MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), 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 886.1120 - 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 - K930442

510(k) Number K930442 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.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 113
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K930442.
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NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · Canon USA, Inc. · Oct 1989