Clinical Laserthermia Systems, AB
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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.
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.
The TRANBERG CLS Thermal Therapy System consists of three parts: TRANBERG CLS Mobile Laser, TRANBERG CLS Temperature Sensor, and Applicator Kit. The mobile laser unit is provided with a laser light that is locally applied by means of a percutaneous procedure. The energy is monitored by a temperature sensor to ensure proper tissue heating and lesion treatment.
Summary parsed at:2026-06-01 06:10:21 UTC
Avenda Health Treatment System
1 submission cite K142216 as a predicate
