Cleared Traditional

GALLIE CRYONUCLEATOR (K833747) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833747 · Mono Research Laboratories · Ophthalmic device
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May 1984
Decision
196d
Days
Class 2
Risk

K833747 is an FDA 510(k) clearance for the GALLIE CRYONUCLEATOR. Classified as Unit, Cryophthalmic (product code HPS), Class II - Special Controls.

Submitted by Mono Research Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 196 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - 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.

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Submission Details

510(k) Number K833747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date May 09, 1984
Days to Decision 196 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 110d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HPS Unit, Cryophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
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.