Dual Switch

Laser Engineering, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K211605
Device name
Dual Switch
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-05-25
Decision date
2022-09-22
Submission type
Special
Technology type
CO2(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

Intended Use

The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

Device Description

The Aurora MD-30 CO2 Laser is a Carbon Dioxide (CO2) surgical laser system that can deliver up to 30 watts of laser power in the 11.2-micron range in the infrared. The laser can be used in a variety of surgical specialties. The power can be selectively delivered either through an articulated arm or through infrared fibers using an integrated electromechanically controlled optical switch that directs the beam either vertically into the articulated arm or at an angle into the fiber. The laser can operate in either continuous wave, pulsed or super pulse modes. It can deliver laser power down to ½ a watt and can operate down to millisecond pulse widths. The system also has a visible aiming beam to indicate where the CO2 laser beam will be delivered. The laser system has a 12-inch highly visible color touchscreen to control the laser. It consists of a small self-contained floor standing, easily moveable console which contains the laser and all associated electronics and delivery systems. The Aurora MD-30 CO2 Laser has an integrated dual switch adapter that is operated by an electrical linear motor and controlled by the console. The switch allows the user to redirect the laser beam from the articulated arm to the fiber as desired.

Summary parsed at:2026-06-01 05:38:14 UTC

Predicate devices

2

K211605 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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