AccessGUDID - DEVICE: LB1 applicator (07290016540024)

GUDID

Device Identifier (DI) Information

Brand Name: LB1 applicator
Version or Model: AS100006
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VENUS CONCEPT LTD

Primary DI Number: 07290016540024
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45213	Radio-frequency skin contouring system applicator, bipolar	A bipolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes between the two tips of this device during treatment, and not through the patient to a return electrode. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBX	Massager, Vacuum, Radio Frequency Induced Heat
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143554	000
K191528	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: 9ee752ae-9430-47a0-a95d-2d5b0f545cb8
Public Version Date: June 16, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016