Epic Hygiene Diode Laser System 7410006

GUDID 00647529003817

A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.

BIOLASE, INC.

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• Primary Device ID: 00647529003817
• NIH Device Record Key: 06f8954c-a3eb-4a4d-a0c8-b5e6a7e40e8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic Hygiene Diode Laser System
• Version Model Number: 7410006
• Catalog Number: 7410006
• Company DUNS: 152165700
• Company Name: BIOLASE, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529003817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192430

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

[00647529003817]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-30
• Device Publish Date: 2019-12-21

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• 00647529004159: A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedur