Waterlase Laser System Gold Handpiece

GUDID 00647529002483

A reusable handpiece intended for use with Waterlase laser systems 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 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: 00647529002483
• NIH Device Record Key: f72cf2eb-1f6b-4495-aff1-c73522765c8f
• Commercial Distribution Discontinuation: 2018-08-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Waterlase Laser System Gold Handpiece
• Version Model Number: 6200500 Refurbished
• 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
• 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	00647529002483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101658

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

[00647529002483]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-08-10
• Device Publish Date: 2016-09-15

On-Brand Devices [Waterlase Laser System Gold Handpiece ]

• 00647529002483: A reusable handpiece intended for use with Waterlase laser systems in a variety of dental hard-t
• 00647529002278: A reusable contra-angled handpiece intended for use with Waterlase laser systems in a variety of