Legend Pro 30020000U

GUDID 07290016586138

LEGEND PRO PACKED Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.

POLLOGEN LTD

Radio-frequency skin surface treatment system

• Primary Device ID: 07290016586138
• NIH Device Record Key: 0dc4f0c3-4b91-43cb-b59c-56b5c6464550
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legend Pro
• Version Model Number: Legend Pro
• Catalog Number: 30020000U
• 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: true
• 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	07290016586138 [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