# K223588: PALLAS Premium

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Jan 26, 2023 after 56 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: 8 generations back to K885026 (1989). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191501: PALLAS 308/311 Solid-State UV Laser System, Laseroptek Co., Ltd. (2020) Summary page 4.
- K193478: XTRAC Momentum Excimer Laser System, Strata Skin Sciences, Inc. (2020) Summary page 5.

## Indications for use
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Source page: https://510kreport.com/device/K223588
Methodology: https://510kreport.com/methodology