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

• 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.

• 00647529004647 - Diode Laser Tips: 2024-05-07 An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
• 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.