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The ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

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This document is a 510(k) clearance letter from the FDA for the Zerona Z6 OTC device. It does not contain information about acceptance criteria, device performance, or study details.

Therefore, I cannot provide the requested information. The letter only confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated use.

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The Zerona® Z6 OTC device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

Zerona® Z6 OTC

The provided document is a 510(k) premarket notification letter from the FDA for the Zerona® Z6 OTC device. It primarily focuses on the substantial equivalence determination and regulatory information.

This document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving those criteria. The letter refers to indications for use but does not provide a table of acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, adjudication methods, or information about MRMC or standalone performance studies.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device