# K123293: Pastelle Q-Switched ND: Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Won Technology Co., Ltd.
- Decided: Apr 11, 2013 after 171 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: 16 generations back to K943450 (1995). 250 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 3.
- K080248: Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces, Lutronic Corporation (2008) Summary page 2.
- K083899: Revlite Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2009) Summary page 2.

## Most influential descendants
- K202288: Finebeam (2021), 2 descendants of its own
- K260256: Q-Switched Nd: YAG Laser Systems (2026), 0 descendants of its own
- K250165: Pastelle (2025), 0 descendants of its own
- K250936: Q-Switched Nd:YAG Laser (SHE-LSP101-1) (2025), 0 descendants of its own
- K243780: HELIOS 785 Pico (1754V2) (2025), 0 descendants of its own

## Indications for use
WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Source page: https://510kreport.com/device/K123293
Methodology: https://510kreport.com/methodology