Epic 10 Diode Laser System 7400042

GUDID 00647529000168

A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. 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 footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.

BIOLASE, INC.

Dental diode laser system

• Primary Device ID: 00647529000168
• NIH Device Record Key: ce3e89b5-96fa-4c70-a77a-f0bb226ae8ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic 10 Diode Laser System
• Version Model Number: 7400042
• Catalog Number: 7400042
• 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
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529000168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121286

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

[00647529000168]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-15

On-Brand Devices [Epic 10 Diode Laser System]

• 00647529002452: A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted too
• 00647529000168: A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assist