Clinical Laserthermia Systems, AB
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The TRANBERGCLS| Laser Applicator 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, for wavelengths 980nm through 1064nm.
The TRANBERGCLS| Laser Applicator 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, for wavelengths 980nm through 1064nm.
The TRANBERG® Laser Applicator is used to transfer laser energy from the laser unit to the location for the treatment. The laser Applicator is designed with a core of 550 μm. The fiber length is 3 and 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The Laser Applicator is used with an introducer and both (fiber and introducer), are delivered sterile and for single use only. The introducer consists of an introducer stylet and introducer catheter with a fiber lock.
Summary parsed at:2026-06-01 05:41:18 UTC
