# K203799: ProFlex CO2 Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Innovaquartz, LLC
- Decided: Sep 20, 2021 after 266 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: 2 generations back to K921671 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100384: Fiberlase C02 Laser Waveguide, Lumenis, Ltd. (2010) Summary page 4.

## Most influential descendants
- K243588: Single Use CO2 Laser Fiber (HAF005001) (2025), 0 descendants of its own

## Indications for use
ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K203799
Methodology: https://510kreport.com/methodology