Manufacturer
Clinical Laserthermia Systems, ABTranberg CLS Thermal Therapy System
Clinical Laserthermia Systems, AB
Country / Region:Sweden (SE)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K142216
- Device name
- Tranberg CLS Thermal Therapy System
- Country / Region
- Sweden(SE)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-08-12
- Decision date
- 2015-04-21
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
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.
Intended 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.
Device Description
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
Predicate devices
2Cited as predicate
1Avenda Health Treatment System
1 submission cite K142216 as a predicate