# K043173: Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Jan 31, 2005 after 76 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: 5 generations back to K950019 (1995). 11 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001) Summary page 2.
- K033259: Light Age Q-Clear Laser, Model 701-1101, Light Age, Inc. (2004) Summary page 2.
- K003460: Palomar Clear Light ND: Yag Laser System, Palomar Medical Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K142860: Lumenis M22 System (2015), 38 descendants of its own
- K170060: M22 and ResurFx Systems (2017), 24 descendants of its own
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System (2020), 12 descendants of its own
- K203441: The Alma Hybrid Laser System (2021), 5 descendants of its own
- K202884: SR-1 Skin Treatment System (2021), 4 descendants of its own

## Indications for use
The Q-switched Nd:YAG Laser Treatment Head for the Quantum series in indicated for: Removal of dark tattoos Treatment of pigmented lesions

Source page: https://510kreport.com/device/K043173
Methodology: https://510kreport.com/methodology