Epic X Diode Laser System 7400073R

GUDID 00647529004173

A dental diode laser system 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 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: 00647529004173
• NIH Device Record Key: e464bbd3-cbb7-41f6-ae15-5662aa01cf44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic X Diode Laser System
• Version Model Number: 7400073 Replacement
• Catalog Number: 7400073R
• 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	00647529004173 [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

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

Moist Heat or Steam Sterilization

[00647529004173]

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 X Diode Laser System]

• 00647529002476: A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted too
• 00647529000175: A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assist
• 00647529004173: A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted too