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The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.

The provided text (K060567) is a 510(k) summary for the SpectraGenics ATS-1, a light therapy device for moderate inflammatory acne vulgaris. However, it does not contain any information regarding acceptance criteria, device performance, or details of a clinical study.

The document primarily focuses on:

• The administrative details of the 510(k) submission (applicant, contact, date, device name, classification, predicate devices).
• A brief description of the device and its intended use.
• A statement that "Clinical data is provided to demonstrate the safety and efficacy of the SpectraGenics ATS-1."
• The FDA's letter of clearance, confirming substantial equivalence to predicate devices, but no specifics about the clinical data itself.
• The "Indications for Use" statement.

Therefore, I cannot provide the requested information. The document merely states that clinical data was provided, but does not summarize or present that data, nor does it detail acceptance criteria or the specifics of a study.

To answer your request, I would need a different document that actually describes the clinical study performed for the SpectraGenics ATS-1, including its methodology, results, and acceptance criteria.

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