Psoria-Shield AURORA

Light, Ultraviolet, Dermatological

Psoria-Shield

The following data is part of a premarket notification filed by Psoria-shield with the FDA for Psoria-shield Aurora.

Pre-market Notification Details

Device IDK192411
510k NumberK192411
Device Name:Psoria-Shield AURORA
ClassificationLight, Ultraviolet, Dermatological
Applicant Psoria-Shield 409 Mandeville St Utica,  NY  13502
ContactJohn Yorke
CorrespondentJohn Yorke
Psoria-Shield 409 Mandeville St Utica,  NY  13502
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-04
Decision Date2020-07-02

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