Emvera

GUDID 00863267000301

808nm Diode Hair Removal Laser System Body

EMVERA TECHNOLOGIES, LLC

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• Primary Device ID: 00863267000301
• NIH Device Record Key: 5c23e837-aacd-4fd0-a5ae-78d8c9440dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emvera
• Version Model Number: Diolux
• Company DUNS: 079501638
• Company Name: EMVERA TECHNOLOGIES, LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com
• Phone: 1-888-886-8402
• Email: info@emvera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863267000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123257

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2019-04-01
• Device Publish Date: 2016-11-28

On-Brand Devices [Emvera]

• 00863267000318: Hand piece to be used with the Emvera Diolux Hair Removal Laser
• 00863267000301: 808nm Diode Hair Removal Laser System Body