FDA Product Code GWE: Stimulator, Photic, Evoked Response
Leading manufacturers include Metrovision, Micromed S.P.A. and Diagnosys, LLC.
49
Total
49
Cleared
178d
Avg days
1978
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Stimulator, Photic, Evoked Response Devices (Product Code GWE)
49 devices
Cleared
Nov 22, 2022
E3 and Profile
Diagnosys, LLC
Ophthalmic
186d
Cleared
Nov 21, 2022
Vision Monitor- MonCvONE
Metrovision
Ophthalmic
432d
Cleared
Sep 23, 2021
LED PHOTIC System
Micromed S.P.A.
Neurology
90d
Cleared
Jul 26, 2021
Vision Monitor - MonpackONE
Metrovision
Ophthalmic
60d
About Product Code GWE - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code GWE since 1978, with 49 receiving FDA clearance (average review time: 178 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
GWE devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →