# K201466: Tranberg CLS Laser Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Laserthermia Systems, AB
- Decided: Mar 26, 2021 after 297 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963081 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163103: Tranberg CLS Diffusor Laser Fiber, Clinical Laserthermia Systems, AB (2017) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K201466
Methodology: https://510kreport.com/methodology