Cleared Traditional

K162756 - PHAKOS Disposable Retinal Cryo Probe

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

K162756 · Phakos · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162756

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.

HRN Device Classification - Class 2, Special Controls

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

All 7
Devices cleared under the same product code (HRN) and FDA review panel - the closest regulatory comparables to K162756.
MIRA Adapter
K200911 · Phakos · Jun 2020
Frigitronics adapter
K180195 · Phakos · Mar 2018
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787 · Keeler, Ltd. · Dec 2013
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093 · Keeler Instruments, Inc. · Dec 2011
CRYOMATIC
K062412 · Keeler Instruments, Inc. · Nov 2006
KEELER CRYO MASTER & PROBES
K992954 · Keeler Instruments, Inc. · Dec 1999