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LS-905 FiberChoice Adapter System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K974229

by Laser Peripherals, Llc

Identifiers

510(k) Number
K974229 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 LS-905 FiberChoice Adapter System is a medical device classified under product code GEX, designed as an adapter for non-standard laser output ports. It facilitates the connection of Laser Peripherals laser fibers to Laserscope-manufactured lasers, enabling compatibility between these systems. This adapter is intended for use in surgical settings where laser fibers require interfacing with specific laser platforms.

The system is supplied as a reusable component and is intended for use in surgical specialties where Laserscope lasers have received regulatory clearance. It is not described as sterile or single-use in the available data. The adapter was cleared under the FDA’s 510(k) pathway (K974229) as substantially equivalent to a predicate device, with review by the Surgical and Urological Devices Advisory Committee. No specific MRI safety or sterility information is provided in the regulatory records.

Frequently asked questions

What is the LS-905 FiberChoice Adapter System used for?

The LS-905 FiberChoice Adapter System bridges non-standard laser output ports, allowing Laser Peripherals laser fibers to interface with Laserscope-manufactured lasers. This ensures seamless compatibility between these systems in surgical environments where specific laser platforms are required. It is designed for use in specialties where Laserscope lasers have received regulatory clearance.

Is the LS-905 FiberChoice Adapter System single-use or reusable?

The LS-905 FiberChoice Adapter System is supplied as a reusable component. This design choice supports cost efficiency and reduces waste, making it suitable for repeated use in clinical settings where sterility can be maintained through proper cleaning and maintenance protocols.

Does the LS-905 FiberChoice Adapter System come sterile?

The available data does not specify that the LS-905 FiberChoice Adapter System is sterile. Reusable medical devices like this typically require cleaning and sterilization between uses, so clinicians must follow established protocols to ensure safety and prevent contamination.

Which surgical specialties is the LS-905 FiberChoice Adapter System intended for?

The adapter is intended for surgical specialties where Laserscope lasers have received regulatory clearance. This includes general, plastic surgery, and other fields where laser-based procedures are performed. The adapter’s compatibility ensures it can be used in these settings without modification.

What regulatory pathway was used for the LS-905 FiberChoice Adapter System?

The LS-905 FiberChoice Adapter System was cleared through the FDA’s 510(k) pathway, specifically under clearance number K974229. It was determined to be substantially equivalent to a predicate device and reviewed by the Surgical and Urological Devices Advisory Committee (SU). This pathway confirms its compliance with U.S. regulatory standards for medical devices.

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: LS-905 FIBERCHOICE ADAPTER SYSTEM (K974229) — FDA 510(k) | Innolitics, K974229 FDA 510 (k) - LS-905 FIBERCHOICE ADAPTER SYSTEM, fda.innolitics.com, LS-905 FIBERCHOICE ADAPTER SYSTEM 510(k) K974229 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laser Peripherals, Llc

Sources (1)

  • FDA 510(k) K974229 24 fields · synced Oct 1, 2026