Clinical Laserthermia Systems, AB
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology at a wavelength of 1064nm.
The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology at a wavelength of 1064nm.
The TRANBERG CLS Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with human tissue is biocompatible. The TRANBERG CLS Laser fiber is delivered sterile and for single use only.
Summary parsed at:2026-06-01 06:05:02 UTC
