Laser-Assisted Disk Decompression Accessory Pack
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K922213 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 Laser-Assisted Disk Decompression Accessory Pack is a surgical accessory designed to assist in laser-assisted disk decompression procedures. It is intended for use with powered laser surgical instruments to facilitate tissue removal or decompression in spinal interventions, typically within the field of general and plastic surgery.
This accessory pack is supplied as a single-use item and is regulated under FDA 510(k) clearance (K922213) with a classification under product code GEX. It is intended for use in sterile surgical environments and is not reusable. No specific MRI safety information is provided in the available data.
Frequently asked questions
What types of surgical procedures is this accessory pack designed to assist with, and what kind of surgical setting does it require?
This accessory pack is specifically designed to assist in laser-assisted disk decompression procedures, which are typically performed in spinal interventions. It is intended for use with powered laser surgical instruments to help remove tissue or decompress spinal disks. Since it is labeled for sterile surgical environments, it must be used in operating rooms or sterile procedure settings where such interventions are conducted, such as general or plastic surgery suites.
Is this accessory pack reusable, or is it meant for single-use only? How does this affect its handling and storage?
The Laser-Assisted Disk Decompression Accessory Pack is explicitly labeled as a single-use item, meaning it should not be reused after a single procedure. This classification ensures patient safety and sterility, as reuse could introduce contamination or compromise device integrity. Proper storage should follow manufacturer guidelines to maintain sterility until first use, typically in a sealed, sterile packaging until opened.
What does the product code GEX indicate about this device’s regulatory classification, and how does it relate to its intended use?
The product code GEX categorizes this device under the FDA’s classification system for electrosurgical and laser accessories. This code reflects that the accessory pack is regulated as a surgical accessory rather than a standalone device, meaning it is intended to be used in conjunction with powered laser instruments during procedures like disk decompression. The classification ensures it meets safety and performance standards for its role in spinal interventions.
How was this device’s equivalence to predecessor technologies determined, and what does the Substantially Equivalent (SESE) decision mean for clinicians?
The Substantially Equivalent (SESE) decision under the FDA’s 510(k) clearance process (K922213) means that the Laser-Assisted Disk Decompression Accessory Pack was compared to legally marketed predecessors and found to have the same intended use, technological characteristics, and performance as those prior devices. Clinicians can rely on this determination to infer that the accessory pack meets established safety and effectiveness standards for its role in laser-assisted disk decompression procedures, though they should always follow the manufacturer’s instructions for use.
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: Laser-assisted Disk Decompression Accessory Pack, LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK 510 (k) K922213 - FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922213 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K922213 24 fields · synced Sep 19, 2026