Cleared Traditional

OPHTHALMIC CRYO UNIT (K940373) - FDA 510(k) Clearance

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

K940373 · Dutch Ophthalmic USA, Inc. · Ophthalmic device
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Jul 1994
Decision
173d
Days
Class 2
Risk

K940373 is an FDA 510(k) clearance for the OPHTHALMIC CRYO UNIT. Classified as Unit, Cryophthalmic (product code HPS), Class II - Special Controls.

Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 173 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.

View all Dutch Ophthalmic USA, Inc. devices

Submission Details

510(k) Number K940373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date July 18, 1994
Days to Decision 173 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 110d · This submission: 173d
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.