# K111831: MX-7000 Microxel

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: Dec 19, 2011 after 174 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: 15 generations back to K910422 (1992). 187 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100610: Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems, Lutronic Corporation (2011) Summary page 1.
- K100590: Edge CO2 Laser System, Jm System Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K173359: Fractional CO2 Surgical Laser System (2018), 0 descendants of its own

## Indications for use
MX-7000 C02 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry. When used in fractionated mode, the MX-7000 C02 system is intended to be used for ablative skin re-surfacing, Wrinkle, Fine lines, Ryhlides, Furrow in Dermatology, in Plastic surgery, and in General surgery.

Source page: https://510kreport.com/device/K111831
Methodology: https://510kreport.com/methodology