Legend Pro 20900330U

GUDID 07290016586176

Legend Pro VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin.

POLLOGEN LTD

Radio-frequency skin surface treatment system

• Primary Device ID: 07290016586176
• NIH Device Record Key: 0244a49e-bbb3-4fbd-ac4d-ac1bd2406099
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legend Pro
• Version Model Number: Legend Pro
• Catalog Number: 20900330U
• Company DUNS: 514905681
• Company Name: POLLOGEN LTD
• Device Count: 1
• DM Exempt: true
• 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	07290016586176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173503

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-12

On-Brand Devices [Legend Pro]

• 07290016586176: Legend Pro VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homog
• 07290016586169: LP APPLICATOR 3 Applicators 1-3 provide RF energy that heats biological tissue in a controlled f
• 07290016586152: LP APPLICATOR 2 Applicators 1-3 provide RF energy that heats biological tissue in a controlled
• 07290016586145: LP APPLICATOR 1 Applicators 1-3 provide RF energy that heats biological tissue in a controlled f
• 07290016586138: LEGEND PRO PACKED Applicators 1-3 provide RF energy that heats biological tissue in a controlled