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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryophthalmic, Ac-Powered
510(k) Number K162756
Device Name PHAKOS Disposable Retinal Cryo Probe
Applicant
Phakos
62 Rue Kleber
Montreuil,  FR 93100
Applicant Contact OLIVER AUMAITRE
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number886.4170
Classification Product Code
HRN  
Date Received09/30/2016
Decision Date 05/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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