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K Number
K123237
Device Name
ZERONA 2.0 LASER
Manufacturer
ERCHONIA CORPORATION
Date Cleared
2013-01-25

(101 days)

Product Code
OLI
Regulation Number
878.5400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Erchonia® Zerona™ 2.0 Laser is indicated for use as a noninvasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary for the Erchonia® Zerona™ 2.0 Laser. It primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical study reports or comprehensive device documentation.

Therefore, I cannot provide the requested information from the given text. The document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set or data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • Information on a multi-reader, multi-case study or effect size.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • Method for establishing ground truth for the training set.

The document only states the "Indications for Use" for the device, which is "as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs." To find the specifics of how this claim was substantiated, one would need to refer to the actual studies conducted by Erchonia Corporation and submitted to the FDA, which are not part of this 510(k) summary letter.

§ 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.