# K243957: Picoalex

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Mar 12, 2025 after 79 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: 24 generations back to K943450 (1995). 278 ancestors in all.
No later device cites it as a predicate yet.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210226: PicoSure Workstation, Cynosure, LLC (2021) Summary page 6.

## Indications for use
PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.

Source page: https://510kreport.com/device/K243957
Methodology: https://510kreport.com/methodology