# K142216: Tranberg CLS Thermal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Laserthermia Systems, AB
- Decided: Apr 21, 2015 after 252 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: 3 generations back to K952661 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092197: PHOTEX30 Diode Laser Series: 980, 810, 940, Biotex, Inc. (2009) Summary page 4.

## Most influential descendants
- K201687: Avenda Health Treatment System (2020), 0 descendants of its own

## Indications for use
The Tranberg CLS Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Source page: https://510kreport.com/device/K142216
Methodology: https://510kreport.com/methodology