đź“Š Evidence-Based Reference
Surgiflex Laser Contact TIPS
Cabot Medical
Summary: Surgiflex Laser Contact Tips are used in laser-assisted surgeries. Primarily for soft tissue applications, they are FDA-cleared with evidence supporting their efficacy in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K894186 ↗
Decision Date ?
September 12, 1989
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The Surgiflex Laser Contact Tips were cleared through the FDA 510(k) pathway on September 12, 1989. Manufactured by Cabot Medical, they are classified as Class 2 devices.
What It Is
Surgiflex Laser Contact Tips are designed for use in laser-assisted surgical procedures, providing precision in soft tissue ablation. They are intended for clinical applications requiring controlled laser energy delivery.
FDA-Cleared Indications
- Use with compatible laser systems for laser-assisted surgical procedures involving soft tissue.
- Deliver laser energy through a contact tip for controlled soft-tissue ablation or modification.
Clinical Applications
- Contact laser treatment of soft tissue during surgery.
- Controlled removal or modification of soft tissue.
- Use in periodontal soft-tissue procedures when performed with a compatible cleared laser system.
- Laser-assisted procedures requiring direct tissue contact and localized energy delivery.
Evidence Summary
The literature includes 10 studies, ranging from case reports to randomized controlled trials, published between 2008 and 2024. These studies explore various clinical applications and outcomes of laser contact tips.
Reported Outcomes
Published studies report that the Surgiflex Laser Contact Tips are effective in reducing tissue damage and improving procedural outcomes in periodontal therapy. They have been shown to maintain energy output and surface integrity during use.
Safety Profile
Reported complications include potential surface alterations of the tips after prolonged use, which may affect energy output. However, no significant adverse events have been consistently documented across studies.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore additional clinical applications.
Practical Considerations
- The tips must be used with a compatible laser generator and according to the device-specific instructions for use.
- Tip dimensions, connector design, and optical compatibility should be confirmed before use; the available FDA record does not specify a complete size range.
- Laser safety precautions are required, including appropriate wavelength-specific eye protection and control of reflective or flammable materials.
- The tip should be inspected for damage, contamination, or loss of optical performance before use and handled according to the manufacturer's reprocessing or single-use instructions.
- MRI safety status is not established by the available 510(k) information; do not bring the device into the MRI environment unless current labeling confirms its status.
Frequently Asked Questions
What are the clinical indications for Surgiflex Laser Contact Tips?
The device is indicated for use in soft tissue surgeries, including periodontal therapy, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported effective tissue ablation with minimal damage and maintained energy output during procedures.
What complications have been reported?
Safety data indicate potential surface alterations of the tips, which may impact performance, but no major adverse events have been reported.
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.