# K180036: SMAXEL CO2 Surgical Laser System

- Pathway: 510(k) (Special)
- Applicant: Ids, Ltd.
- Decided: Feb 2, 2018 after 28 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Recalls of this device
- Oct 16, 2024 · Class II · Z-0804-2025: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

## Indications for use
The SMAXEL (formally the MX-7000 MICROXEL) Fractional C02 Laser System is indicated for use in non-fractional mode is incision, excision, ablation, vaporization, and coagulation of human soft tissue. Intended for use in Dermatology, Plastic and General Surgery, Gynecology, Neurosurgery, and Podiatry. When used in fractional mode, the SMAXEL Fractional C02 Laser System indications for use in ablative skin re-surfacing, wrinkles, fine lines, rhylides, and furrows in Dermatology, Plastic and General Surgery.

Source page: https://510kreport.com/device/K180036
Methodology: https://510kreport.com/methodology