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510(k) Data Aggregation
K Number
K201466Device Name
Tranberg CLS Laser Applicator
Manufacturer
Clinical Laserthermia Systems, AB
Date Cleared
2021-03-26
(297 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Clinical Laserthermia Systems, AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRANBERG® 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.
Device Description
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.
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