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The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and in dermatology.

The MeDioStar laser system is intended for the treatment of benign vascular lesions.

The MeDioStar laser system is intended for the treatment of benign pigmented lesions.

The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

The MeDioStar is a pulsed diode laser emitting a wavelength of 750 - 950 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.

This document is a 510(k) Pre-Market Notification for a medical device, specifically a laser system. It outlines the modifications to an existing device, the MeDioStar, and demonstrates its substantial equivalence to previously cleared predicate devices.

Based on the provided document, there is no information regarding acceptance criteria, reported device performance metrics against those criteria, or clinical study details (sample size, data provenance, expert adjudication, MRMC, standalone algorithm performance, ground truth establishment for test or training sets).

The document explicitly states: "Clinical Performance Data: None".

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through:

1. Technical Modifications: Listing specific changes from the predicate device (e.g., GUI design, handpiece port, repetition rate, handpieces, USB drive).
2. Comparison of Technical Characteristics: A table comparing the subject device (MeDioStar) to its main predicate (MeDioStar NeXT Family) and two reference predicates (Primelase Excellence, LightSheer Infinity/Duet/Desire) across various parameters like laser source, wavelength, pulse duration, fluence, repetition rate, intended use, and handpiece ports.
3. Non-clinical Performance Data: Listing standards to which the device complies (e.g., ISO 60601-1, IEC 62304, ISO 14971) and stating that software verification and validation testing were conducted successfully.

The FDA 510(k) process for this device type often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring new clinical studies and performance benchmarks against specific acceptance criteria. This is particularly true for modifications to existing cleared devices, as is the case here ("Special 510(k)").

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