Identifiers
- 510(k) Number
- K920625 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lateralase Catheter is a surgical device classified under the product code GEX for General and Plastic Surgery. It is designed for use in laser-assisted procedures, specifically for tissue ablation or coagulation within surgical contexts, leveraging laser energy to achieve precise medical effects.
This device is intended for single-use and is regulated under FDA 510(k) clearance through the Traditional pathway. It is supplied sterile and falls under Class II medical device classification. The device is associated with multiple FDA submissions (K920625, K925414, K944204), all filed under the product code GEX for General and Plastic Surgery applications.
Frequently asked questions
What types of surgical procedures is the Lateralase Catheter designed for, and how does it work?
The Lateralase Catheter is designed for laser-assisted procedures in surgical contexts, specifically for tissue ablation or coagulation. It uses laser energy to deliver precise medical effects, making it suitable for applications in general and plastic surgery where controlled tissue modification is required. The device’s design allows surgeons to target and treat tissue with accuracy, reducing damage to surrounding areas.
Is the Lateralase Catheter reusable, or is it intended for single-use only?
The Lateralase Catheter is intended for single-use only, as explicitly stated in its design and regulatory documentation. This ensures sterility and safety for each procedure, reducing the risk of cross-contamination or device degradation between uses.
How is the Lateralase Catheter supplied, and is it sterile upon receipt?
The Lateralase Catheter is supplied sterile directly to the user, ready for immediate surgical use. This eliminates the need for additional sterilization steps, streamlining the procedural workflow while maintaining infection control standards.
What regulatory pathway was followed for FDA clearance of the Lateralase Catheter, and what does this mean for its use?
The Lateralase Catheter received FDA clearance through the Traditional 510(k) pathway, where it was determined to be substantially equivalent to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness in its intended surgical applications, specifically within general and plastic surgery procedures. The clearance was granted under product code GEX, confirming its classification as a Class II device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K925414 - LATERALASE CATHETER | FDA 510 (k) | Trimedyne, Inc., LATERALASE (K920625) — FDA 510(k) | Innolitics, LATERALASE CATHETER (K925414) — FDA 510 (k) | Innolitics, K944204 - LATERALASE | FDA 510 (k) | Trimedyne, Inc., LATERALASE CATHETER 510(k) K925414 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920625 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K920625 24 fields · synced Sep 19, 2026