Modified Luxar Lx-20 Family CO2 Laser System
510(k) K953074
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953074 | Date28 Aug 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Luxar LX-20 Family CO₂ Laser System is a surgical laser device designed for precise tissue interaction, enabling controlled excision, coagulation, or vaporisation. As a carbon dioxide laser, it operates at wavelengths suitable for dermatological, plastic, and general surgical procedures. Its modular design incorporates a sealed CO₂ laser source capable of delivering up to 20 watts of laser energy, tailored for clinical applications requiring high precision. The system is classified under product code GEX, reflecting its role in general surgical and plastic surgery settings.
The device is intended for use in sterile surgical environments by trained medical personnel, including physicians. It is supplied as a reusable system with integrated computer monitoring to ensure safe and reliable operation, including performance tracking of the laser output. The system’s accessories, such as the patterning handpiece and associated cabling, extend its functionality for specialised surgical techniques. No specific sterility or MRI safety information is provided in the data, and its regulatory status is confirmed by FDA 510(k) clearance under K953074, with a decision date of August 28, 1995.
Other devices from Luxar Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Luxar LX-20 CO₂ Laser System used for?
The Luxar LX-20 CO₂ Laser System is designed for controlled tissue interaction in surgical procedures, including excision, coagulation, or vaporisation. Its carbon dioxide laser wavelength makes it suitable for dermatological, plastic, and general surgical applications where precision is critical. The system’s modular design and 20-watt output enable tailored use in clinical settings requiring high accuracy.
Is the Luxar LX-20 CO₂ Laser System reusable or single-use?
The Luxar LX-20 CO₂ Laser System is supplied as a reusable device. It includes integrated computer monitoring to ensure safe and reliable operation, including performance tracking of laser output. Accessories like the patterning handpiece and cabling are also reusable, provided they are maintained according to manufacturer guidelines.
What are the key specifications of the Luxar LX-20 CO₂ Laser System?
The system operates as a sealed CO₂ laser source with a maximum output of 20 watts, making it versatile for procedures requiring precision. It falls under FDA product code GEX, indicating its use in general and plastic surgery. The device is classified as substantially equivalent under FDA 510(k) clearance (K953074), with a decision date of August 28, 1995.
Does the Luxar LX-20 CO₂ Laser System include any special accessories?
Yes, the Luxar LX-20 CO₂ Laser System includes accessories such as a patterning handpiece, which extends its functionality for specialised surgical techniques. These accessories are designed to work seamlessly with the reusable system, enhancing its versatility in clinical environments.
What safety features does the Luxar LX-20 CO₂ Laser System incorporate?
The system incorporates integrated computer monitoring to ensure safe operation, including real-time performance tracking of the laser output. This feature helps maintain reliability and precision during surgical procedures. However, no specific sterility or MRI safety information is provided in the available data.