Cleared Traditional

K160591 - D.O.R.C. Disposable Cryo Probe (FDA 510(k) Clearance)

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

K160591 · Dutch Ophthalmic Research Center International BV · Ophthalmic device
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Jan 2017
Decision
328d
Days
Class 2
Risk

K160591 is an FDA 510(k) clearance for the D.O.R.C. Disposable Cryo Probe. Classified as Unit, Cryophthalmic, Ac-powered (product code HRN), Class II - Special Controls.

Submitted by Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on January 23, 2017 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Research Center International BV devices

Submission Details

510(k) Number K160591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date January 23, 2017
Days to Decision 328 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
218d slower than avg
Panel avg: 110d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRN Unit, Cryophthalmic, Ac-powered
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.