# K101321: Ematrix CO2

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Nov 9, 2010 after 182 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). 288 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071051: Fraxel Iii SR Laser System and Accessories, Reliant Technologies, Inc. (2007) Summary page 1.
- K072182: Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060, Alma Lasers, Ltd. (2008) Summary page 1.
- K080463: Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories, Alma Lasers, Ltd. (2008) Summary page 1.

## Most influential descendants
- K151655: CO2RE System (2015), 1 descendant of its own
- K181523: Syneron CO2RE System (2018), 0 descendants of its own

## Indications for use
Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

Source page: https://510kreport.com/device/K101321
Methodology: https://510kreport.com/methodology