Search Results

Exilite system (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The Exilite device is indicated for the primary treatment of dermatologic deficiencies. It is Intense Pulsed Light System which uses a wide spectrum of light from 480 to 1200nm (yellow, green, red and infrared light).

The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the handpiece is equipped with trigger button, enabling to start the application instead of footswitch.

Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the chosen therapy and applied filter, the set fluence and other necessary data.

The Exilite consists of the following main components:

• . control unit
• user interface with 8.4" color touch screen .
• . handpiece with cooling sapphire crystal and trigger button

The provided document describes the FDA 510(k) clearance for the Exilite system, an Intense Pulsed Light (IPL) device. The clearance is based on substantial equivalence to a predicate device, not on a clinical study demonstrating the device's performance against specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of diagnostic or AI-powered medical devices.

Instead, the document focuses on:

• Indications for Use: Reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth.
• Non-clinical Testing: Compliance with electrical safety, risk management, software lifecycle, electromagnetic compatibility, and biological evaluation standards (ISO 14971, IEC 62304, ISO 60601-1, ISO 60601-1-2, ISO 10993-5, ISO 10993-10).
• Comparison with a Predicate Device: The Exilite system is compared to the Intense Pulsed Light (IPL) Systems from Beijing KES Biology Technology Co., Ltd. (K122995) based on technical characteristics such as light source, emitted by, operation, wavelength, deliver system, electrical protection, maximal fluence, pulse delay, pulse duration, pulse type, and cooling method.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided 510(k) summary. The substantial equivalence determination was made based on technical characteristics and safety standards rather than a clinical performance study with specific outcome measures.

The document explicitly states: "The substantial equivalence determination for the Exilite system is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the Exilite as compared to the predicate devices."

Ask a specific question about this device