Waterlase Express Handpiece 7220001

GUDID 00647529001509

A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue procedures.

Biolase, Inc.

Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system

• Primary Device ID: 00647529001509
• NIH Device Record Key: 171ad9fc-9395-4e47-b527-d620a781bd07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterlase Express Handpiece
• Version Model Number: Handpiece, Single Unpacked
• Catalog Number: 7220001
• 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: false
• 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: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529001509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161669

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

Moist Heat or Steam Sterilization

[00647529001509]

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

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• 00647529001509: A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of de