# K180993: Beacon Advanced CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: Jun 28, 2018 after 73 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: 7 generations back to K936109 (1994). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151331: The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch, Lumenis, Ltd. (2015) Summary page 4.

## Indications for use
The Beacon Advanced Energy CO2 Laser System Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties: Dermatology, General Surgery, Gynecology, Head & Neck Surgery, Neurosurgery, Oral Surgery, Orthopedic Surgery in soft tissue, Otolaryngology, Plastic & Reconstructive Surgery, Podiatry, Urology.

Source page: https://510kreport.com/device/K180993
Methodology: https://510kreport.com/methodology