HRN · Class II · 21 CFR 886.4170

FDA Product Code HRN: Unit, Cryophthalmic, Ac-powered

Leading manufacturers include Keeler Instruments, Inc., Phakos and Terumo Medical Corp..

10
Total
10
Cleared
126d
Avg days
1983
Since

FDA 510(k) Cleared Unit, Cryophthalmic, Ac-powered Devices (Product Code HRN)

10 devices
1–10 of 10
Cleared Jun 02, 2020
MIRA Adapter
K200911
Phakos
Ophthalmic · 57d
Cleared Mar 16, 2018
Frigitronics adapter
K180195
Phakos
Ophthalmic · 51d
Cleared May 03, 2017
PHAKOS Disposable Retinal Cryo Probe
K162756
Phakos
Ophthalmic · 215d
Cleared Jan 23, 2017
D.O.R.C. Disposable Cryo Probe
K160591
Dutch Ophthalmic Research Center International BV
Ophthalmic · 328d
Cleared Dec 23, 2013
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787
Keeler, Ltd.
Ophthalmic · 188d
Cleared Dec 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093
Keeler Instruments, Inc.
Ophthalmic · 139d
Cleared Nov 06, 2006
CRYOMATIC
K062412
Keeler Instruments, Inc.
Ophthalmic · 81d
Cleared Oct 22, 2001
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K012821
Dutch Ophthalmic USA, Inc.
Ophthalmic · 60d
Cleared Dec 21, 1999
KEELER CRYO MASTER & PROBES
K992954
Keeler Instruments, Inc.
Ophthalmic · 111d
Cleared Jan 08, 1983
CLIRANS TE08 HOLLOW FIBER DIALYZER
K823768
Terumo Medical Corp.
Ophthalmic · 25d

About Product Code HRN - Regulatory Context