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lightscalpel family of handpiece tips for co2 surgical lasers
Lightscalpel
Summary: The Lightscalpel family of handpiece tips are used with CO2 surgical lasers for precise tissue cutting and ablation. They are primarily used by surgeons in various specialties for minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K121471 ↗
Decision Date
July 10, 2012
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The Lightscalpel handpiece tips were cleared through the FDA 510(k) pathway on July 10, 2012. Manufactured by Lightscalpel, this device is classified as Class 2 under product code GEX.
What It Is
The Lightscalpel handpiece tips are designed for use with CO2 surgical lasers, which emit a focused beam of light that can cut, ablate, or vaporize soft tissue with high precision. These tips allow for enhanced control and accuracy during surgical procedures, minimizing damage to surrounding tissues. The device is particularly valued for its ability to perform bloodless surgeries with reduced postoperative pain and faster healing.
Clinical Applications
These handpiece tips are commonly used in surgical settings such as dermatology, otolaryngology, gynecology, and general surgery. They are ideal for procedures requiring precision, such as excisions, incisions, and ablations. The device is suitable for both outpatient and inpatient settings, and it is used in patient populations ranging from pediatric to adult.
Indications for Use
The FDA-cleared indications for the Lightscalpel handpiece tips include their use in surgical procedures that require precise cutting and ablation of soft tissues. This makes them suitable for treating conditions that benefit from minimally invasive surgical techniques.
Practical Considerations
The Lightscalpel handpiece tips come in various sizes to accommodate different surgical needs and are compatible with Lightscalpel CO2 lasers. Surgeons should be trained in laser safety and technique to maximize the benefits of the device. Proper maintenance and sterilization of the tips are essential for optimal performance.
Frequently Asked Questions
What is the Lightscalpel handpiece tips used for?
The Lightscalpel handpiece tips are used for precise cutting and ablation of soft tissues in various surgical procedures.
What specialties typically use this device?
Specialties such as dermatology, otolaryngology, gynecology, and general surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring precise cutting and ablation of soft tissues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.