Cleared Traditional

PHAKOS Disposable Retinal Cryo Probe

K162756 · Phakos · Ophthalmic

May 2017

Decision

215d

Days

Class 2

Risk

About This 510(k) Submission

K162756 is an FDA 510(k) clearance for the PHAKOS Disposable Retinal Cryo Probe, a Unit, Cryophthalmic, Ac-powered (Class II — Special Controls, product code HRN), submitted by Phakos (Montreuil, FR). The FDA issued a Cleared decision on May 3, 2017, 215 days after receiving the submission on September 30, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number	K162756 FDA.gov
FDA Decision	Cleared 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