Search Results

for use in the treatment of pigmented lesions and tattoos.

The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components:

• the high voltage power supply and modulator system; 1)
• 2. the optical laser head;
• 3. the circulator system;
• 4. the microprocessor-based system controller and user display panel;
• 5. the optical delivery system.

The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment.

The provided 510(k) summary for the Candela Q-Switched Alexandrite Lasers does not contain the requested information about acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

This document describes a medical device, specifically a laser, and its substantial equivalence to predicate devices (other lasers). The "Testing" section mentions "component testing and functional testing of the completed laser," which refers to engineering and quality control tests for the physical device, not an AI or algorithm performance study with ground truth and expert adjudication.

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance. The summary explicitly states: "No new questions of safety and efficacy are raised by the introduction of this device into commercial distribution," which points to a traditional substantial equivalence argument for a physical medical device, not a software or AI-driven diagnostic or prognostic tool.

Ask a specific question about this device