# K040171: Microderm, Model/Version 3.5

- Pathway: 510(k) (Traditional)
- Applicant: Visiomed AG
- Decided: Jun 8, 2004 after 134 days
- Product code: PSN (Light Based Imaging)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010259 (2001). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032760: Apax Pacs System, Tis, Inc. (2003) Summary page 4.

## Most influential descendants
- K192829: Demetra BDEM-01 Dermatoscope (2019), 2 descendants of its own
- K230448: DeepX DermoSight Dermatoscope (2023), 0 descendants of its own
- K213957: Demetra Dermatoscope BDEM-01 (2022), 0 descendants of its own

## Indications for use
MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.,

Source page: https://510kreport.com/device/K040171
Methodology: https://510kreport.com/methodology