Beacon Advanced CO2 Laser System

Omniguide, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

8

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K180993
Device name
Beacon Advanced CO2 Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-04-16
Decision date
2018-06-28
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Beacon Advanced Energy CO2 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, Otolaryngology, Plastic & Reconstructive Surgery, Podiatry, Urology.

Intended Use

The Beacon Advanced Energy CO2 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.

Device Description

The Beacon Advanced Energy Laser System is a carbon dioxide laser system utilizing RF excited CO2 laser tube. The device is comprised of a system console, with or without an articulated arm terminated with a handpiece or a micromanipulator, a fiber adapter, system control electronics, a touch screen providing a graphical user interface, a covered footswitch, helium gas management system, and operating software. The laser system delivers laser energy at 10,600 nm in three different output modes: continuous, single pulse and repeat pulse and two waveforms: Continuous Wave (CW) or Super Pulse (SP). The laser energy produced by the laser tube within the laser console is delivered through an articulated arm system terminating in a handpiece or multiple-use attachments or through a fiber adaptor coupling the laser energy into a OmniGuide waveguide. The articulating arm allows the laser energy to be delivered through a focusing handpiece or a micromanipulator achieving laser beam spot sizes in the range of 0.2-0.6 mm in the operating field. The Beacon is operated and controlled via Graphical User Interface implemented by proprietary operating software running on single board computer in the laser console. The operator can control various aspects of the Beacon operation through the Graphical User Interface on the touch screen. The access to the Graphical User Interface and laser operation is password protected to control access. The operator can adjust the lasing modes, pulse rate and duration in case of pulsed modes, set the waveform (CW or SP) and output power. Material used are mainly machined or cast aluminum, stainless steel, standard optics for the transmission or the reflection of the CO2 laser wave energy.

Summary parsed at:2026-06-01 05:57:30 UTC

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