# K040563: LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System (25 Watt)

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Oct 8, 2004 after 219 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 K936109 (1994). 26 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.
- K953074: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1995) Summary page 1.

## Most influential descendants
- K093793: LS-40 CO2 Laser System Model LS-40 (2010), 3 descendants of its own
- K110897: Cortex CO2 / ER:Yag Laser System (2011), 2 descendants of its own
- K150587: Cortex Laser System (2015), 1 descendant of its own
- K161356: Matrix LS-40 CO2 Laser System (2016), 0 descendants of its own
- K082101: LS Family of CO2 Lasers with Scanning Handpiece (2008), 0 descendants of its own

## Indications for use
Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

Source page: https://510kreport.com/device/K040563
Methodology: https://510kreport.com/methodology