Epic Hygiene Diode Laser System 7420006

GUDID 00647529004159

A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedures. The dental diode laser 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.

Dental diode laser system

• Primary Device ID: 00647529004159
• NIH Device Record Key: e4f3a277-1c16-4927-a0b8-affe4014781b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic Hygiene Diode Laser System
• Version Model Number: Handpiece, 1pk
• Catalog Number: 7420006
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529004159 [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

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

[00647529004159]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [Epic Hygiene Diode Laser System]

• 00647529003817: A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The system i
• 00647529004166: A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The system i
• 00647529004159: A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedur