Search Results

The MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications: - Excision and Incision Biopsies - Hemostatic assistance - Treatment of Apthous Ulcers - Frenectomy - Frenotomy - Gingival Incision and Excision - Gingivectomy - Gingivoplasty - Incising and Draining of Abscesses - Operculectomy - Oral Papillectomy - Removal of Fibromas - Soft Tissue Crown Lengthening - Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) - Tissue retraction for Impression - Vestibuloplasty - Laser assisted whitening/bleaching of teeth - Light activation for bleaching materials for teeth whitening

The proposed devices, MIRA LASERS ZENO 2 and MIRA LASERS ZENO 4, are new device for 510(k) submission and share the same indication for use and safety compliance, similar design features and functional features with the predicate device. The proposed device are designed to be compact, portable, reliable and user-friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions and vaporization of tissues to periodontal treatments and tooth whitening. The MIRA LASERS at 810mm are delivered through a flexible optical fiber, or fixed disposable tip. The systems may be utilized for a wide variety of dental surgical and cosmetic procedures. The proposed devices include two models, the difference of the two models is only laser power, the laser power of ZENO 2 is 0.6W/1.2W/1.8W, and the laser power of ZENO 4 is 1.0w/2.0/3.5W. The MIRA LASERS are contained within a compact lightweight plastic/metal housing and consists of a laser diode assembly with a self-contained cooling system, a slim battery pack, front panel display all connected to a circuit board, which controls laser output power and other system parameters for laser proper functioning. The proposed device includes two different working modes, which are continuous wave and 20Hz pulse.