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aesculight family of flexible fibers handpieces and tips for co2 surgical lasers
Aesculight
Summary: The Aesculight family of flexible fibers handpieces and tips are CO2 surgical lasers used for precise cutting and coagulation in various surgical procedures. They are typically used by surgeons in fields such as dermatology, gynecology, and general surgery.
FDA Clearance Information
Pathway
510K
Number
K081612 ↗
Decision Date
June 25, 2008
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The Aesculight CO2 surgical lasers were cleared through the FDA 510k pathway on June 25, 2008, by Aesculight. It is classified as a Class 2 medical device under product code GEX.
What It Is
The Aesculight CO2 surgical laser system consists of flexible fiber handpieces and tips designed for surgical applications. These lasers emit a concentrated beam of CO2 light, which is absorbed by water in the tissues, allowing for precise cutting and coagulation with minimal thermal damage to surrounding tissues. This makes it an effective tool for surgeries requiring precision and control.
Clinical Applications
Aesculight CO2 lasers are commonly used in dermatological procedures for excising skin lesions, in gynecology for procedures like LEEP, and in general surgery for tissue ablation and incision. They are particularly useful in outpatient settings and specialized surgical centers where precision and reduced recovery time are priorities. The device is suitable for a wide range of patient populations, including those requiring delicate tissue handling.
Indications for Use
The FDA-cleared indications for the Aesculight CO2 lasers include surgical procedures requiring precise cutting and coagulation. It is used for conditions where minimizing thermal damage and ensuring precise tissue removal are critical.
Practical Considerations
The Aesculight CO2 laser system offers various handpiece sizes and tips to accommodate different surgical needs. It is compatible with standard surgical equipment and requires proper training for optimal use. Clinicians should be aware of the laser's power settings and tissue interaction to maximize efficacy and safety.
Frequently Asked Questions
What is Aesculight CO2 surgical laser used for?
It is used for precise surgical cutting and coagulation in procedures across dermatology, gynecology, and general surgery.
What specialties typically use this device?
Dermatologists, gynecologists, and general surgeons commonly use this device for its precision and control.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring precise cutting and coagulation, minimizing thermal damage to surrounding 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.