Plasma IQ System 100-1200

GUDID 00850017374003

PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of a targeted micro beam of plasma energy. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

NEAUVIA NORTH AMERICA, INC.

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• Primary Device ID: 00850017374003
• NIH Device Record Key: 5ad1682f-2186-4a36-96c3-b2eed731580d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasma IQ System
• Version Model Number: PLK-755
• Catalog Number: 100-1200
• Company DUNS: 117030786
• Company Name: NEAUVIA NORTH AMERICA, INC.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775292
• Email: misty@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com
• Phone: 9847775296
• Email: joy@neauvia-us.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017374003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192813

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: 2020-09-22
• Device Publish Date: 2020-09-14

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