Model Ls-870 CO2 Surgical Laser System (Modified)
by Cooper Lasersonics, Inc. 510(k)
Active
510(k) K860831
Overview
The Model LS-870 CO₂ Surgical Laser System (Modified) is a powered laser surgical instrument designed for precise tissue ablation, coagulation, and vaporisation. It operates using a carbon dioxide (CO₂) laser, delivering high-energy laser beams for surgical procedures in various specialties. This device is classified under the GEX product code, covering powered laser surgical instruments. Its modified configuration maintains the core functionality of a CO₂ laser system while potentially incorporating updated safety or performance enhancements.
This system is intended for use in controlled surgical environments, such as operating rooms, where sterile conditions are maintained. It is classified as a Class II medical device under FDA regulations and has received a 510(k) clearance (K860831) for substantial equivalence to a predicate device. The device is not described as single-use or reusable in the available data, though its design suggests it may require maintenance or recalibration. No specific MRI safety or sterility requirements beyond standard surgical protocols are noted in the provided details.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860831 | Date2 Oct 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Cooper Lasersonics, Inc.
Questions
What is the LS-870 CO₂ Surgical Laser System (Modified) used for?
The LS-870 CO₂ Surgical Laser System (Modified) is a powered laser instrument designed for precise surgical procedures, including tissue ablation, coagulation, and vaporization. It uses a carbon dioxide (CO₂) laser to deliver high-energy beams, making it suitable for various specialties like general and plastic surgery in controlled environments such as operating rooms.
Is the LS-870 CO₂ Surgical Laser System (Modified) single-use or reusable?
The available data does not explicitly state whether the LS-870 CO₂ Surgical Laser System (Modified) is single-use or reusable. However, given its classification as a powered surgical instrument and the mention of potential maintenance or recalibration needs, it is likely intended for reuse with proper upkeep. Standard surgical protocols for cleaning and sterilization would apply in a clinical setting.
What regulatory clearance does the LS-870 CO₂ Surgical Laser System (Modified) hold?
The LS-870 CO₂ Surgical Laser System (Modified) has received FDA 510(k) clearance under the reference number K860831. This clearance establishes substantial equivalence to a predicate device, allowing it to be marketed in the U.S. under the GEX product code, which covers powered laser surgical instruments.
Does the LS-870 CO₂ Surgical Laser System (Modified) require any special storage conditions?
The provided details do not specify unique storage requirements beyond standard operating room conditions for surgical lasers. As with any medical device used in sterile environments, it should be stored in a clean, dry location, protected from physical damage, and maintained according to manufacturer guidelines to ensure optimal performance and safety.
What safety or performance enhancements distinguish the modified version of the LS-870?
The modified version of the LS-870 retains the core functionality of a CO₂ laser system but may include updated safety or performance improvements. While the exact enhancements are not detailed, the modification suggests refinements to align with evolving clinical or regulatory standards, potentially improving usability or reducing risks in surgical applications.