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Optomed Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K201325Optomed Smartscope M5 with Optomed Smartscope FANovember 20, 2020
K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleApril 5, 2018
K163021HAAG-STREIT FUNDUS MODULE 300April 11, 2017
K132186OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2December 18, 2013
K110986OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1May 16, 2011
K092056OPTOMED SMARTSCOPE, MODEL M3-1 EY1October 1, 2009
K990417DERMACOOLApril 14, 1999
K923531OPTOSCALPEL I LASER SYSTEMNovember 12, 1993