# K091115: ECO2 Laser System

- Pathway: 510(k) (Special)
- Applicant: Lutronic Corporation
- Decided: Oct 30, 2009 after 196 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: 13 generations back to K910422 (1992). 153 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080496: Mosaic ECO2 Laser System, Lutronic Corporation (2008) Summary page 1.
- K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories, Reliant Technologies, Inc. (2008) Summary page 1.
- K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.
- K031224: Smartxide, Cynosure, Inc. (2003) Summary page 1.

## Most influential descendants
- K123573: Youlaser CO2 Laser (2013), 19 descendants of its own
- K160312: Fraxis Duo (2016), 14 descendants of its own
- K170325: Secret RF (2017), 10 descendants of its own
- K210084: Silkro (2022), 3 descendants of its own
- K180654: PINXEL-RF system (2018), 3 descendants of its own

## Indications for use
The eCO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

Source page: https://510kreport.com/device/K091115
Methodology: https://510kreport.com/methodology