# K193478: XTRAC Momentum Excimer Laser System

- Pathway: 510(k) (Special)
- Applicant: Strata Skin Sciences, Inc.
- Decided: Jan 14, 2020 after 29 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K885026 (1989). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073659: Xtrac Ultra 2, Model AL10000, Photo Medex, Inc. (2008) Summary page 4.

## Most influential descendants
- K223588: PALLAS Premium (2023), 0 descendants of its own

## Indications for use
UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Source page: https://510kreport.com/device/K193478
Methodology: https://510kreport.com/methodology