Device Dossier
Dermatological solid-state laser system
Device Dossier for Dermatological solid-state laser system (Dermatological solid-state laser system, Class IIb, sponsor Bella Derm). ARTG record,…
- GMDN category: Dermatological solid-state laser system
Intended purpose
The MIIN Laser is a Q-switched Nd:YAG laser system intended for use in dermatological and aesthetic treatments. It is designed to deliver high-intensity, short-pulsed laser energy for the treatment of benign pigmented lesions and tattoo removal through the process of selective photothermolysis, effectively targeting chromophores in the skin while minimising thermal damage to surrounding tissues. This device is intended for use by qualified healthcare professionals, dermatologists, cosmetic physicians, and appropriately trained therapists in medical, dermatological, and aesthetic clinic settings. The MIIN Laser is indicated for: Treatment of benign pigmented lesions, including freckles, solar lentigines, café-au-lait macules, melasma, and post-inflammatory hyperpigmentation. Tattoo removal, by targeting exogenous ink particles in professional, amateur, and traumatic tattoos, fragmenting pigment for gradual clearance via the body's immune response. General dermatological and aesthetic applications, where Q-switched Nd:YAG laser treatment is clinically appropriate. The MIIN Laser is classified as a laser-based medical device and must be used in compliance with manufacturer guidelines, laser safety protocols, and applicable regulatory requirements to ensure safe and effective treatment outcomes.