# K110897: Cortex CO2 / ER:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Jul 1, 2011 after 93 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 K936109 (1994). 35 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093793: LS-40 CO2 Laser System Model LS-40, Sandstone Medical Technologies, LLC (2010) Summary page 1.
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System, Medical Laser Technologies, LLC (2003) Summary page 1.

## Most influential descendants
- K150587: Cortex Laser System (2015), 1 descendant of its own
- K161356: Matrix LS-40 CO2 Laser System (2016), 0 descendants of its own

## Indications for use
The C02 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or 6utting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

Source page: https://510kreport.com/device/K110897
Methodology: https://510kreport.com/methodology