Laser Peripherals, LLC Family of Bare Laser Fibers

Laser Peripherals, LLC

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

9

Cited as predicate

6

Device details

FDA 510(k) registration fields

K number
K170366
Device name
Laser Peripherals, LLC Family of Bare Laser Fibers
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-02-06
Decision date
2017-06-08
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm — 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.

Intended Use

The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm — 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.

Device Description

The Family of Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including open, laparoscopic or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. The key components of this system are the SMA-905, SMA-906 and Manufacturer's specific connectors and the Fiber Optic. Laser Peripherals is responsible for the design, testing and manufacturing of the Family of Surgical Laser Fibers. The Family of Surgical Laser Fibers are broken down into different models, e.g., Wavelength/Laser Compatible and Disposable versus Re-usable. The proximal end of the laser fiber always features a connector. The main purpose of the connector is to provide a robust connection to the laser and align the fiber to the laser energy output beam. The fiber optic in the laser fiber is the main component in the assembly and is what allows for delivering the energy to the patient. The fiber portion of the laser fiber is comprised of several different materials; these can be thought of as: the fiber core, fiber cladding and coating layers, and the outside coating or the jacket. All fibers featured in this submission have a core consisting of a silica (glass) material.

Summary parsed at:2026-06-01 05:59:43 UTC

Predicate devices

9

K170366 references 9 predicate/reference devices

Cited as predicate

6

6 submissions cite K170366 as a predicate