# K243588: Single Use CO2 Laser Fiber (HAF005001)

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Feb 19, 2025 after 91 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: 3 generations back to K921671 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203799: ProFlex CO2 Laser Fiber, Innovaquartz, LLC (2021) Summary page 5.

## Indications for use
Single Use CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.

Source page: https://510kreport.com/device/K243588
Methodology: https://510kreport.com/methodology