đź“Š Evidence-Based Reference
Novatip Family of Laser Handpiece TIPS
Xanova
Summary: The Novatip family of laser handpiece tips, manufactured by Xanova, is primarily used in surgical procedures involving the portal vein. Key evidence highlights its role in photobiomodulation and laser-assisted surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K971539 ↗
Decision Date ?
June 3, 1997
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The Novatip laser handpiece tips were cleared by the FDA via the 510(k) pathway on June 3, 1997. Manufactured by Xanova, these devices are classified as Class 2 under product code GEX.
What It Is
The Novatip laser handpiece tips are designed for use in surgical procedures, utilizing laser technology to assist in tissue manipulation and photobiomodulation. They are intended for clinical applications involving the portal vein and other related surgical contexts.
FDA-Cleared Indications
- Use as a laser handpiece tip with a compatible laser system during surgical procedures, as specified in the cleared labeling.
- The available FDA summary does not state a sufficiently specific vessel, organ, or procedure indication.
Clinical Applications
- Laser-assisted surgical procedures performed with a compatible laser generator and handpiece.
- Tissue-directed laser procedures when the specific tip and laser system are used according to the cleared labeling.
- Clinical procedures in which the cleared laser system is indicated for photobiomodulation, if included in the system labeling.
Evidence Summary
The available literature includes three studies, ranging from 2004 to 2021, encompassing randomized controlled trials and other study types. These studies explore the efficacy of laser technology in various clinical applications.
Reported Outcomes
Published studies report that the Novatip laser tips are effective in enhancing pre-osteoblast proliferation and viability through photobiomodulation. Additionally, they are noted for their precision in laser-assisted surgeries, particularly in the upper aero-digestive tract and dental applications.
Safety Profile
Reported complications include the potential for confusion in nomenclature and procedural classification, as highlighted in the literature. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and specific efficacy metrics. Further research is needed to explore long-term outcomes and to clarify procedural classifications and nomenclature.
Practical Considerations
- Confirm compatibility with the laser generator, handpiece, fiber or connector, and any required accessories before use.
- The record does not provide tip diameters, working lengths, wavelengths, or other size specifications; consult the manufacturer’s current instructions for use.
- Laser safety precautions are required, including appropriate eye protection, controlled access, and protection from unintended tissue exposure.
- MRI safety status is not established in the available record. Do not assume the tip or connected laser equipment is MR Safe or MR Conditional without manufacturer documentation.
- Inspect the tip and packaging before use and follow the labeled instructions for sterilization, single-use status, reprocessing, and disposal.
Frequently Asked Questions
What are the clinical indications for Novatip laser tips?
The Novatip laser tips are indicated for use in surgical procedures involving the portal vein and other related contexts, as well as in laser-assisted surgeries of the upper aero-digestive tract and dental applications.
What outcomes have been reported in clinical studies?
Clinical studies have reported enhanced pre-osteoblast proliferation and viability through photobiomodulation, as well as precision in laser-assisted surgeries.
What complications have been reported?
Reported complications include potential confusion in procedural nomenclature and classification, with no specific adverse events detailed in the studies.
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.