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510(k) K040171

MICRODERM, MODEL/VERSION 3.5 by Visiomed AG — Product Code PSN

K040171 is an FDA 510(k) premarket notification submitted by Visiomed AG for the device "MICRODERM, MODEL/VERSION 3.5". The FDA issued a decision of Substantially Equivalent on June 8, 2004. The device falls under product code PSN (Light Based Imaging), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2004
Date Received
January 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

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FDA data resources