Search Results

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 he 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)

The provided text describes the FDA 510(k) clearance for the Optimas MAX System, comparing it to predicate devices. However, it does not contain information about acceptance criteria or specific study details proving the device meets those criteria, particularly regarding an AI component or machine learning performance.

The document focuses on the substantial equivalence of the hardware and general system functionality, including:

• Indications for Use: Listing the intended applications of the system's various applicators (hair removal, vascular lesions, pigmented lesions, muscle aches/pains, soft tissue coagulation/hemostasis).
• Technological Characteristics: Describing the system as a computerized device generating Laser, IPL, and RF energies, with a new industrial design and an upgraded operating system (Linux from Windows CE). It explicitly states that "The specifications for the critical components of the system remain unchanged," and "The system components, handpiece connectors, and the operating parameters of each handpiece remains unchanged."
• Non-Clinical and/or Clinical Tests Summary: Mentions "software validation testing to demonstrate that the system's new Burst and Scale Modes for the Morpheus8 handpieces function as expected" and new electrical testing against various IEC standards.

Therefore, based solely on the provided text, I cannot describe acceptance criteria and a study proving the device meets them in the context of AI or machine learning performance, as that information is not present. The clearance process described is typical for a hardware device with minor software updates and cosmetic changes, relying on substantial equivalence to previously cleared devices.

To answer your request, if an AI/ML component was implicitly part of "software validation testing" or "Burst and Scale Modes," the document does not provide the specifics you're asking for.

If this were an AI/ML device, the FDA clearance would typically include sections detailing:

• Performance Metrics: Sensitivity, specificity, AUC, etc.
• Dataset Details: Size, provenance, diversity.
• Ground Truth: How it was established (e.g., expert consensus, pathology).
• Reader Study: If human-in-the-loop performance was evaluated.

Since none of that information is in the provided text, I must state that the document does not contain the details to fulfill your request.

Ask a specific question about this device