đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in surgical procedures requiring Nd:YAG laser energy for tissue cutting, vaporization, or coagulation, as specified in the device labeling.
- Use with compatible surgical tips and fibers identified for the Sharplan 2100 laser system.
Clinical Applications
- Laser-assisted surgical excision or vaporization of soft tissue when the selected tip or fiber is labeled for that application.
- Coagulation of soft tissue and control of bleeding during indicated surgical procedures.
- Use in operating-room or procedure-room settings by trained clinicians following the system’s laser-safety and accessory labeling.
Practical Considerations
- The laser system must be used with compatible Sharplan Series 2900 Syn Tips, fibers, handpieces, and other accessories; the accessory labeling determines the permitted tissue and procedure.
- Nd:YAG energy can penetrate relatively deeply, so power, pulse duration, delivery method, and tissue contact require careful adjustment to limit unintended thermal injury.
- Use requires trained personnel, appropriate eye protection, controlled access, warning signage, and other operating-room laser-safety measures.
- The device is not an implant and is not intended to remain in the body. MRI status is generally not applicable to the laser console, but detachable accessories and any other equipment in the MRI environment must be evaluated separately.
- Contraindications, precautions, tissue limitations, and accessory compatibility should be taken from the original FDA-cleared labeling and current manufacturer documentation; the available record does not establish a specific list of indications for oncology, dermatology, vascular, adult, or pediatric use.
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.