Manufacturer
Laser Engineering, Inc.Dual Switch
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K211605
- Device name
- Dual Switch
- Company
- Laser Engineering, Inc.
- 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
