Optomed OY - FDA 510(k) Cleared Devices
Recent clearances: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, HAAG-STREIT FUNDUS MODULE 300, OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optomed OY Ophthalmic ✕
5 devices
Cleared
Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Ophthalmic
52d
Cleared
Apr 11, 2017
HAAG-STREIT FUNDUS MODULE 300
Ophthalmic
162d
Cleared
Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
Ophthalmic
156d
Cleared
May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
Ophthalmic
38d
Cleared
Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
Ophthalmic
86d