LB1 applicator

GUDID 07290016540024

The Venus Legacy device is intended for the treatment of the following medical conditions; using the applicators for delivery of non-thermal RF comb

VENUS CONCEPT LTD

Radio-frequency skin contouring system applicator, bipolar

• Primary Device ID: 07290016540024
• NIH Device Record Key: 9ee752ae-9430-47a0-a95d-2d5b0f545cb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LB1 applicator
• Version Model Number: AS100006
• Company DUNS: 533127663
• Company Name: VENUS CONCEPT LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016540024 [Primary]
GS1	07290016540147 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143554

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by VENUS CONCEPT LTD

• 07290016541632 - BLISS SYSTEM: 2021-07-22 The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with
• 07290016541564 - BODY LASER APPLICATOR SERVICE PACK, Bliss: 2021-07-22
• 07290016541618 - (MP)2 APPLICATOR BLISS: 2021-07-22
• 07290016541625 - BODY LASER APPLICATOR BLISS: 2021-07-22
• 07290016541717 - (MP)2 APPLICATOR SERVICE PACK, Bliss: 2021-07-22
• 07290016541724 - Belt Bliss: 2021-07-22
• 07290016541984 - Epileve Applicator Service Pack UDI Label: 2021-07-22 The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic
• 27290016541179 - HR 690XL Light Block package: 2020-05-01