General/multiple surgical solid-state laser system

Intended purpose

The Thulium Laser System is an active, non-invasive medical device intended for use in dermatological procedures requiring the delivery of non-ionising laser energy for the coagulation of soft tissue and the treatment of benign skin lesions. The device is indicated for the treatment of actinic keratosis and benign pigmented lesions, including lentigos (age spots), solar lentigos (sun spots), and ephelides (freckles). The system emits laser energy at approximately 1927 nm, which is delivered to the treatment area via a handpiece to achieve a controlled thermal effect in the target tissue. The device is intended for use by trained healthcare professionals in clinical settings