Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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.
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.
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
