# K220793: InnoVoyce Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Innovoyce, LLC
- Decided: May 25, 2022 after 68 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: 24 generations back to K943450 (1995). 403 ancestors in all.
No later device cites it as a predicate yet.
0 of 404 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220189: LISA Laser Surgical Fibers, Omni-Guide Holdings, Inc. (2022). Cleared while this submission was under review Summary page 4.

## Indications for use
InnoVoyce Laser Fiber is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue.

Source page: https://510kreport.com/device/K220793
Methodology: https://510kreport.com/methodology