Manufacturer
Laser Peripherals, LLCLaser Peripherals, LLC Family of Bare Laser Fibers
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K170366
- Device name
- Laser Peripherals, LLC Family of Bare Laser Fibers
- Company
- Laser Peripherals, LLC
- 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
9Cited as predicate
6Surgical laser fibers
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
LISA Laser Surgical Fibers
Air Gap Fiber
VaporMAX LDD; MOJo LDD; MegaJOULE LDD
Lithoblast Single Use Holmium Laser Fibers
6 submissions cite K170366 as a predicate
