Manufacturer
Quanta System SpaSurgical laser fibers
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K200234
- Device name
- Surgical laser fibers
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-01-30
- Decision date
- 2020-02-25
- Submission type
- Special
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Surgical Laser fibers are intended to be used to deliver the laser radiation to the target tissue when used 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.
Intended Use
Surgical Laser fibers are intended to be used to deliver the laser radiation to the target tissue when used 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.
Device Description
The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber. These devices are typically jacketed with ETFE, but some models are characterized by the presence of Nylon coating. The devices are 3.0 meters (9.8 ft) or 5.0 meters (16.4 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and several core diameter sizes (from 200 to 1000 microns) are offered.
Summary parsed at:2026-06-01 05:47:48 UTC
Predicate devices
2Quanta System Surgical Laser fibers
Laser Peripherals, LLC Family of Bare Laser Fibers
K200234 references 2 predicate/reference devices
Cited as predicate
2Litho 60; Litho 100; Litho 150
LGO-Surgical Laser Fibers
2 submissions cite K200234 as a predicate
