Search Results

The GME LinScan Lite 808 Laser System is indicated 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 LinScan Lite 808 Laser System is a diode laser designed to be used in Dermatological practice 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 LinScan Lite 808 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner.

The LinScan Lite 808 System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit.

A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan Lite 808 System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore. Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

The provided text describes a 510(k) summary for the GME LinScan Lite 808 Laser System, which is a medical device for hair removal and permanent hair reduction. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It is crucial to understand that this document does NOT describe the performance of an Artificial Intelligence (AI) device, nor does it present "acceptance criteria" or a "study that proves the device meets acceptance criteria" in the context of AI device performance.

The acceptance criteria and study described in this document are related to the substantial equivalence of a laser system to a predicate device, focusing on its physical characteristics, safety standards (IEC certifications), and intended use, rather than an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for information related to an AI device's acceptance criteria and performance study derived from this document. The document discusses:

• Device Type: A laser system for hair removal.
• Regulatory Pathway: 510(k) premarket notification for substantial equivalence.
• Performance Data (as presented): Conformance to IEC standards (e.g., IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-2), which are safety and electrical performance standards for medical electrical equipment and laser products. These are not performance metrics for an AI algorithm.
• No mention of:
  • AI algorithms or their performance.
  • Test sets, training sets, or ground truth for AI.
  • Expert readers or adjudication for AI.
  • MRMC studies for AI.
  • Sensitivity, specificity, AUC, or other typical AI performance metrics.

In summary, the provided text does not contain any information about an AI device's acceptance criteria or performance study.

Ask a specific question about this device