Clinical Laserthermia Systems, AB

Country / region:Sweden (SE)

510(k) submissions

Latest clearance

2021-03-26

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

4 total

K number	Device name	Product code	Class	Decision date
K201466	Tranberg CLS Laser Applicator	GEX	Class 2	2021-03-26
K163103	Tranberg CLS Diffusor Laser Fiber	GEX	Class 2	2017-03-23
K151569	Tranberg CLS Laser Fiber	GEX	Class 2	2016-02-12
K142216	Tranberg CLS Thermal Therapy System	GEX	Class 2	2015-04-21

Clinical Laserthermia Systems, AB references 6 predicate/reference devices

K201687
Avenda Health Treatment System
Avenda Health, Inc.
Not ingested
K201466
Tranberg CLS Laser Applicator
Clinical Laserthermia Systems, AB
Not ingested
K163103
Tranberg CLS Diffusor Laser Fiber
Clinical Laserthermia Systems, AB
Not ingested

3 submissions cite Clinical Laserthermia Systems, AB as a predicate