Cleared Traditional

K162756 - PHAKOS Disposable Retinal Cryo Probe

K162756 is the FDA 510(k) clearance for PHAKOS Disposable Retinal Cryo Probe by Phakos. It is a Class 2 Ophthalmic device (product code HRN) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K162756 · Phakos · Ophthalmic device
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May 2017
Decision
215d
Days
Class 2
Risk

K162756 is an FDA 510(k) clearance for the PHAKOS Disposable Retinal Cryo Probe. Classified as Unit, Cryophthalmic, Ac-powered (product code HRN), Class II - Special Controls.

Submitted by Phakos (Montreuil, FR). The FDA issued a Cleared decision on May 3, 2017 after a review of 215 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 Phakos devices

Submission Details

510(k) Number K162756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date May 03, 2017
Days to Decision 215 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
105d slower than avg
Panel avg: 110d · This submission: 215d
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.

Regulatory Peers - HRN Unit, Cryophthalmic, Ac-powered

Devices cleared under the same product code (HRN) and FDA review panel - the closest regulatory comparables to K162756.
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