Dental Soft Tissue Laser System 7410008

GUDID 00647529004357

A surgical and therapeutic device 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 surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system

• Primary Device ID: 00647529004357
• NIH Device Record Key: ada4972a-7a0b-4a79-8e6d-a52fd7fe360c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Soft Tissue Laser System
• Version Model Number: Epic Q Laser System
• Catalog Number: 7410008
• 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	00647529004357 [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

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

Moist Heat or Steam Sterilization

[00647529004357]

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

Devices Manufactured by Biolase, Inc.

• 00647529003749 - Waterlase Laser Tips: 2023-08-09 A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
• 00647529003770 - Waterlase iPlus Dental Laser System: 2023-08-09 A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. Th
• 00647529003787 - Waterlase iPlus Dental Laser System: 2023-08-09 A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of so
• 00647529000120 - Diode Laser Tips: 2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
• 00647529000137 - Diode Laser Tips: 2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
• 00647529000687 - Waterlase Laser Tips: 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.
• 00647529000922 - Waterlase Laser Tips: 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.
• 00647529001509 - Waterlase Express Handpiece: 2023-06-27 A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue