# K100590: Edge CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Jm System Co., Ltd.
- Decided: Nov 10, 2010 after 253 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 1 generation back to K081424 (2009). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081424: Affirm CO2 and Affirm CO2 HP, Cynosure, Inc. (2009) Summary page 1.

## Most influential descendants
- K162169: EdgeOne CO2 Laser (2016), 7 descendants of its own
- K201109: CO2 Laser Therapy System (2020), 5 descendants of its own
- K221597: CO2 Laser System (2022), 2 descendants of its own
- K241670: Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (2024), 1 descendant of its own
- K111831: MX-7000 Microxel (2011), 1 descendant of its own

## Indications for use
The Edge CO2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The Edge CO2 laser when used in fractionated mode is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K100590
Methodology: https://510kreport.com/methodology