AccessGUDID - DEVICE: Zerona Z6 (00858985006124)

GUDID

Device Identifier (DI) Information

Brand Name: Zerona Z6
Version or Model: SHR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SHR
Company Name: ERCHONIA CORPORATION, LLC

Primary DI Number: 00858985006124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004053174 *Terms of Use

Device Description: AESTHETIC - Floor Model Low Level Laser -- 6 diodes 635nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58252	Low-intensity laser fat liquefaction system	An assembly of devices designed for the noninvasive application of low-level laser energy [low-level laser therapy (LLLT)] to liquefy (emulsify) subcutaneous and visceral adipose tissue (fat) for cosmetic/aesthetic (e.g., body contouring, circumference reduction) and medical (e.g. weight-loss, lipid reduction) applications. It is a mains electricity (AC-powered) system, mobile on wheels, which incorporates laser diode modules on adjustable arms, a control monitor, and software. It is an independent, primary device which may be used as an adjunct modality in conjunction with liposuction and surgical techniques as a secondary function.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLI	Fat Reducing Low Level Laser

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162578	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fdbb7ce-29cb-4e1d-b827-8580f0dba934
Public Version Date: August 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016