Epic Pro Diode Laser System 7410001P

GUDID 00647529003473

A laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical 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: 00647529003473
• NIH Device Record Key: cb22275e-8176-4957-a195-72449d2d4f7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic Pro Diode Laser System
• Version Model Number: Dental soft tissue diode laser system refurbished
• Catalog Number: 7410001P
• 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: true
• 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	00647529003473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163128

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

Moist Heat or Steam Sterilization

[00647529003473]

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 Pro Diode Laser System]

• 00647529003541: A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dent
• 00647529002605: A laser system intended for a variety of surgical and oral soft-tissue procedures and dental too
• 00647529003558: A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dent
• 00647529003473: A laser system intended for a variety of surgical and oral soft-tissue procedures and dental too