(87 days)
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.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.