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HRN — Unit, Cryophthalmic, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
HRN
Device Class
Class II
Regulation Number
886.4170
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200911phakosMIRA AdapterJune 2, 2020
K180195phakosFrigitronics adapterMarch 16, 2018
K162756phakosPHAKOS Disposable Retinal Cryo ProbeMay 3, 2017
K160591dutch ophthalmic research center internationalD.O.R.C. Disposable Cryo ProbeJanuary 23, 2017
K131787keelerCRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESDecember 23, 2013
K112093keeler instrumentsCRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERDecember 8, 2011
K062412keeler instrumentsCRYOMATICNovember 6, 2006
K012821dutch ophthalmic usaD.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEMOctober 22, 2001
K992954keeler instrumentsKEELER CRYO MASTER & PROBESDecember 21, 1999
K823768terumo medicalCLIRANS TE08 HOLLOW FIBER DIALYZERJanuary 8, 1983