Optimas MAX System

The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal. The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments:
* The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
* The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.
The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The Optimas MAX System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal. The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments: * The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The Optimas MAX System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. The system is compatible with the following applicators: • DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL) • LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA) • VASCULAZE 1064 (previously cleared as Vasculaze) • FORMA (previously cleared as Forma (Plus)) • PLUS (previously cleared as Plus/Plus) • MORPHEUS8 • MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)