AccessGUDID - DEVICE: Zerona AD (00858985006117)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00858985006117
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 532nm 17mW - IFU Reduction of Arms

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):	Yes
Over the Counter (OTC):	No
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 [?]
K121690	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: 43a78805-c4af-4f8d-8a8f-26e68f0911e4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016