LGO-Surgical Laser Fibers

Light Guide Optics International , Ltd.

Country / region:Latvia (LV)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K243147
Device name
LGO-Surgical Laser Fibers
Country / region
Latvia(LV)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-09-30
Decision date
2024-12-21
Submission type
Traditional
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Surgical cuttingOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for 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. Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue with any cleared/certified surgical laser with operational wavelengths between 500nm – 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with. FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm‐ 2140 nm and equipped with SMA 905 compatible connector. FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.

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.

Summary parsed at:2026-06-01 05:29:40 UTC

Predicate devices

2

K243147 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K243147 as a predicate