Manufacturer
Clinical Laserthermia Systems, ABTranberg CLS Diffusor Laser Fiber
Clinical Laserthermia Systems, AB
Country / Region:Sweden (SE)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
- K163103
- Device name
- Tranberg CLS Diffusor Laser Fiber
- Country / Region
- Sweden(SE)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-11-07
- Decision date
- 2017-03-23
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The TRANBERG CLS/Diffusor 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, for wavelengths 980nm through 1064nm.
Intended Use
The TRANBERG CLS/Diffusor 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, for wavelengths 980nm through 1064nm.
Device Description
The TRANBERG CLS/Diffusor Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The diffusor laser fiber is designed with a core of 550 µm. The fiber length is 3 to 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The TRANBERG CLS/Diffusor Laser fiber is delivered sterile and for single use only.
Summary parsed at:2026-06-01 05:59:11 UTC
Predicate devices
1Tranberg CLS Laser Fiber
K163103 references 1 predicate/reference device
Cited as predicate
1Tranberg CLS Laser Applicator
1 submission cite K163103 as a predicate