FDA 510(k) Applications for Medical Device Product Code "HRN"
(Unit, Cryophthalmic, Ac-Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K160591 DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV D.O.R.C. Disposable Cryo Probe 01/23/2017
K012821 DUTCH OPHTHALMIC USA, INC. D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM 10/22/2001
K062412 KEELER INSTRUMENTS, INC. CRYOMATIC 11/06/2006
K112093 KEELER INSTRUMENTS, INC. CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER 12/08/2011
K992954 KEELER INSTRUMENTS, INC. KEELER CRYO MASTER & PROBES 12/21/1999
K131787 KEELER LTD. CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES 12/23/2013
K180195 Phakos Frigitronics adapter 03/16/2018
K200911 Phakos MIRA Adapter 06/02/2020
K162756 PHAKOS PHAKOS Disposable Retinal Cryo Probe 05/03/2017


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact