HRN · Class II · 21 CFR 886.4170

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

Leading manufacturers include Phakos.

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

About Product Code HRN - Regulatory Context