Search Results

The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Nd:YAG handpiece is indicated for:

• At the 1064nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
• At the 532nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er:YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy is a wavelength of 2940nm. This handpiece can be removed and replaced with a q-switch Nd:YAG handpeice emitting wavelengths of 1064nm and 532nm laser energy can be added. The user activates the laser emission by means of a footswitch.

The provided text does not describe any acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) Summary for a medical device (Triplex Er:YAG / Nd:YAG Laser System) seeking FDA clearance. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving efficacy against predetermined performance acceptance criteria through clinical studies.

The document explicitly states:

• "Results of Clinical Study: None" under the "Performance Data" section.
• The conclusion is that the device is "comparable to the predicate device in terms of indications for use, technical specifications, operating performance features, general design."

Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria and studies because the provided document indicates that no such study was performed or required for this type of FDA clearance. The clearance was based on technological characteristics and substantial equivalence, not performance against acceptance criteria derived from a clinical trial.

Ask a specific question about this device