# K230448: DeepX DermoSight Dermatoscope

- Pathway: 510(k) (Traditional)
- Applicant: Deepx Health, LLC
- Decided: May 17, 2023 after 85 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: 4 generations back to K010259 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192829: Demetra BDEM-01 Dermatoscope, Barco N.V. (2019) Summary page 4.
- K040171: Microderm, Model/Version 3.5, Visiomed AG (2004) Summary page 4.

## Indications for use
The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system, which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

Source page: https://510kreport.com/device/K230448
Methodology: https://510kreport.com/methodology