CO2 Laser Coupler
by L.A.S.E.R., Inc. 510(k)
Active
510(k) K983965
Overview
The CO2 Laser Coupler is a surgical accessory designed to connect a CO2 laser articulating arm to laparoscopic instruments. It facilitates precise laser delivery during minimally invasive procedures, enabling controlled tissue interaction in general and plastic surgery applications. This device is classified under product code GEX as a Class 2 medical device, adhering to regulatory standards for laser-based surgical tools.
The CO2 Laser Coupler is intended for single-use in sterile surgical settings, compatible with laparoscopic systems. It requires proper alignment with CO2 laser arms to ensure accurate energy transfer without beam deflection. Supplied as a sterile, disposable component, it must be stored under controlled conditions to maintain integrity. Authorized for use in the United States under an FDA 510(k) clearance (K983965), it follows traditional review pathways for substantial equivalence to predicate devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983965 | Date22 Dec 1998 | 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- Withdrawn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 L.A.S.E.R., Inc.
Questions
What is the CO2 Laser Coupler used for in surgical procedures?
The CO2 Laser Coupler is designed to connect a CO2 laser articulating arm to laparoscopic instruments, enabling precise laser energy delivery during minimally invasive surgeries. This facilitates controlled tissue interaction, making it particularly useful in general and plastic surgery applications where accuracy and minimal invasiveness are critical.
Is the CO2 Laser Coupler intended for single-use or reusable applications?
The CO2 Laser Coupler is explicitly designed for single-use in sterile surgical settings. This ensures patient safety and maintains the integrity of the device, as reusing it could compromise sterility and performance, leading to potential risks during surgery.
How should the CO2 Laser Coupler be stored to maintain its integrity?
The CO2 Laser Coupler must be stored under controlled conditions to preserve its sterility and functionality. Proper storage involves keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight, to prevent degradation or contamination before use.
What regulatory approval does the CO2 Laser Coupler have in the United States?
The CO2 Laser Coupler is authorized for use in the United States under an FDA 510(k) clearance (K983965). This clearance follows a traditional review pathway, demonstrating substantial equivalence to a predicate device, and adheres to regulatory standards for laser-based surgical tools classified under product code GEX.
How does the CO2 Laser Coupler ensure accurate laser energy transfer during surgery?
The CO2 Laser Coupler is engineered to align seamlessly with CO2 laser arms, ensuring minimal beam deflection and precise energy transfer to laparoscopic instruments. Proper alignment is essential to maintain the integrity of the laser beam, enabling surgeons to perform controlled and accurate tissue interactions during minimally invasive procedures.