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The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction.

In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.

The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

Intense Pulsed Light Source

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) notification for the CyDen iPulse i400 System, seeking pre-market approval from the FDA. It outlines administrative information, device design and use characteristics, and the FDA's substantial equivalence determination letter.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No mention of acceptance criteria: The document does not define any specific performance metrics, thresholds, or criteria that the device needs to meet.
• No description of a study: There is no section detailing a clinical trial, performance study, or any other type of investigation conducted to assess the device's efficacy or safety against pre-defined criteria.
• No data on device performance: Consequently, there are no reported device performance results, sample sizes for test sets, data provenance, expert qualifications, or ground truth methodologies.
• No MRMC or standalone study information: These types of studies are not mentioned.
• No training set information: The document does not discuss any training data used for the device, which would be relevant for an AI/algorithm-based device, but this device is an Intense Pulsed Light Source.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for class II medical devices. This typically involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often without requiring extensive new clinical trials if technological characteristics and indications for use are similar. The FDA's letter explicitly states that the determination of substantial equivalence does not mean the FDA has determined the device complies with other requirements of the Act or federal statutes and regulations.

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