TheraClear 40-TC116

GUDID B305THERACLEAR10

THERAVANT CORPORATION

Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator

• Primary Device ID: B305THERACLEAR10
• NIH Device Record Key: c98e917d-5a70-4a8d-8680-0bf06a573dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraClear
• Version Model Number: 40-TC116-00.AA
• Catalog Number: 40-TC116
• Company DUNS: 927989959
• Company Name: THERAVANT CORPORATION
• 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: true
• 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

Customer Support Contacts

• Phone: 925 518-0800
• Email: durrutia@theravantcorp.com
• Phone: 925 518-0800
• Email: durrutia@theravantcorp.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B305THERACLEAR10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123889

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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: 2017-02-14

On-Brand Devices [TheraClear]

• B305THERACLEAR10: 40-TC116-00.AA
• B30530TC0730: 30TC073AA00
• B30530TC0300: 30TC03000AA
• B30520TC1290: 20TC12900AA