Zerona Z6 OTC

• K Number: K162578
• Device Name: Zerona Z6 OTC
• Manufacturer: ERCHONIA CORPORATION
• Date Cleared: 2016-12-16 ( 92 days)
• Product Code: OLI
• Regulation Number: 878.5400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 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.