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510(k) Data Aggregation
K Number
K243147Device Name
LGO-Surgical Laser Fibers
Manufacturer
Light Guide Optics International Ltd.
Date Cleared
2024-12-21
(82 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Light Guide Optics International Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LGO-Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified laser with operational wavelengths between 500 nm - 2200 nm equipped with SMA 905 standard or freestanding ferrule connector, as per the indications of the laser device used with.
Device Description
LGO-Surgical Laser Fibers are a group of single use or reusable with up to 10 total uses EtO sterilized laser powered surgical instruments. They are intended for use in healthcare facilities or hospitals by physicians being familiar with the handling of medical laser devices, and with the therapeutic application of sterile medical optical fibers.
There are two primary product subgroups: Bare Fiber and Side Fire Fiber. Each subgroup encompasses various models on the market, which primarily vary in their distal end design, jacket materials, diameter, length, and usage (single use or 10x reusable). All variations of the LGO-Surgical Laser Fibers feature an SMA-905 connector or a custom special connector at the proximal end for compatibility with appropriate medical laser devices.
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