# K131903: Equinox CO2 Laser

- Pathway: 510(k) (Special)
- Applicant: Eclipse Aesthetics, LLC
- Decided: Sep 19, 2013 after 86 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: 2 generations back to K081424 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100487: Equinox CO2 Laser System, Eclipsemed Global, Inc. (2010) Summary page 1.

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

Source page: https://510kreport.com/device/K131903
Methodology: https://510kreport.com/methodology