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sharplan 2100 nd yag laser series 2900 syn tips
Sharplan Lasers
Summary: The Sharplan 2100 Nd:YAG Laser is a medical device used in surgical procedures for precise tissue excision and coagulation. It is typically used by surgeons in various specialties, including oncology and dermatology.
FDA Clearance Information
Pathway 510K
Number K883563 ↗
Decision Date September 27, 1988
Product Code GEX
Device Class Class 2
Evidence 0 studies
The Sharplan 2100 Nd:YAG Laser received FDA clearance through the 510(k) pathway on September 27, 1988. It is manufactured by Sharplan Lasers and is classified as a Class 2 device.
What It Is
The Sharplan 2100 Nd:YAG Laser is a surgical laser device that utilizes a neodymium-doped yttrium aluminum garnet (Nd:YAG) medium to produce a specific wavelength of light. This laser is capable of deep tissue penetration, making it effective for cutting and coagulating tissue with minimal bleeding. It is often used in procedures where precision and control are critical.
Clinical Applications
This laser is commonly used in surgical oncology for tumor excision, as well as in dermatology for the removal of skin lesions. It is also employed in vascular surgery for the treatment of varicose veins. The device is suitable for use in both hospital and outpatient settings, catering to adult and pediatric patient populations.
Indications for Use
The FDA-cleared indications for the Sharplan 2100 Nd:YAG Laser include surgical procedures requiring precise tissue cutting and coagulation. It is particularly useful for patients needing tumor removal or treatment of vascular conditions.
Practical Considerations
The Sharplan 2100 Nd:YAG Laser is compatible with various surgical tips and fibers, allowing for flexibility in different procedures. Clinicians should be trained in laser safety and operation to ensure optimal outcomes. The device's settings can be adjusted based on the specific clinical scenario.
Related Literature
The linked study investigated the systemic host anti-tumor response following laser excision of tumors in rats. The study compared different excision methods, including the use of the Sharplan 2100 Nd:YAG Laser. Results indicated potential benefits in using laser excision for enhancing anti-tumor responses. However, the study was limited by its animal model and may not fully translate to human clinical outcomes.
Frequently Asked Questions
What is the Sharplan 2100 Nd:YAG Laser used for?
It is used for precise tissue cutting and coagulation in surgical procedures, such as tumor excision and treatment of vascular conditions.
What specialties typically use this device?
Surgeons in oncology, dermatology, and vascular surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring precise cutting and coagulation, including tumor removal and treatment of vascular conditions.
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.