AccessGUDID - DEVICE: Venus Legacy (07290016540000)

GUDID

Device Identifier (DI) Information

Brand Name: Venus Legacy
Version or Model: LE120004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VENUS CONCEPT LTD

Primary DI Number: 07290016540000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533127663 *Terms of Use

Device Description: The Venus Legacy device is intended for the treatment of the following medical conditions; using the applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:  Relief of minor muscle aches and pain, relief of muscle spasm  Temporary improvement of local blood circulation  Temporary reduction in the appearance of cellulite

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Radio-frequency skin contouring system	An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

GMDN Preferred Term Name

GMDN Definition

Radio-frequency skin contouring system

An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

FDA Product Code

[?]

Product Code	Product Code Name
PBX	Massager, Vacuum, Radio Frequency Induced Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143554	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: 5c894829-d580-4e67-90ef-7cfbd79f97ac
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016