(30 days)
The Erchonia Zerona® VZ8 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
The Zerona® VZ8 laser is designed for clients seeking noninvasive circumference reduction without invasive surgery. Zerona® VZ8 allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® VZ8 works by emulsifying adipose tissue which then releases into the interstitial space. Zerona VZ8 was built on the clinical foundation of its predecessors, Violet ZERONA® Z6 and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.
The Zerona® VZ8 is identical to the predecessor device, the Erchonia Violet ZERONA® Z6 OTC cleared under K231474, with the difference in the number of laser diodes (eight compared to six). The Installation and Proper Use Reference Guide for use for the Zerona® VZ8 is identical to the predecessor laser, the Erchonia® Violet ZERONA® Z6 OTC: consisting of the similar treatment set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.
The Zerona® VZ8 emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the eight specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® VZ8 laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas.
The software incorporated into the operation of the Zerona® VZ8 complies with FDA and ISO Software Development and Validation regulations.
The provided text is a 510(k) summary for the Erchonia Zerona® VZ8 device. It states that no clinical study results were submitted as part of this submission, and therefore, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data. The submission relies on demonstrating substantial equivalence to predicate devices, particularly the Erchonia Violet ZERONA Z6 OTC and the Erchonia Emerald, based on similar technology and the safety and efficacy data previously established for those devices.
Specifically, the document states:
- "No clinical study results are being submitted as part of this submission" (Page 7, "Performance Testing-Clinical").
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as presented in the format of the questions, because this information is not present in the provided text. The submission focuses on demonstrating substantial equivalence rather than presenting new clinical performance data for the Zerona® VZ8 itself.
§ 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.