Search Results

The IRIDEX® Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.

The Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light.

The provided text is a 510(k) Summary and an FDA clearance letter for the IRIDEX Apex 800 Dermatology Laser System. It does not contain information on acceptance criteria for a study demonstrating device performance, nor details of such a study.

Therefore, I cannot provide the requested table and study information based on the given input. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, not on proving specific performance criteria through a clinical study with detailed statistical results.

The document indicates that the Apex 800 is substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness are considered to be similar to those already on the market. This type of submission generally relies on comparing the new device's technological characteristics and intended use to existing devices, rather than conducting new, extensive clinical trials to establish new performance metrics.

Ask a specific question about this device