# K173359: Fractional CO2 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ami, Inc.
- Decided: Jul 5, 2018 after 252 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: 16 generations back to K910422 (1992). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111831: MX-7000 Microxel, Bio-Med USA, Inc. (2011) Summary page 4.
- K180036: SMAXEL CO2 Surgical Laser System, Ids, Ltd. (2018). Cleared while this submission was under review Summary page 4.

## Indications for use
The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry. The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

Source page: https://510kreport.com/device/K173359
Methodology: https://510kreport.com/methodology