Waterlase Laser System Turbo Handpiece 6201126

GUDID 00647529002285

A reusable handpiece intended for use with Waterlase laser systems.

BIOLASE, INC.

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• Primary Device ID: 00647529002285
• NIH Device Record Key: 38a21256-17c7-4dbd-b1c1-b7a35eebdf47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterlase Laser System Turbo Handpiece
• Version Model Number: 6201126
• Catalog Number: 6201126
• 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	00647529002285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090181

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

[00647529002285]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Waterlase Laser System Turbo Handpiece ]

• 00647529002469: A reusable handpiece intended for use with Waterlase laser systems.
• 00647529002285: A reusable handpiece intended for use with Waterlase laser systems.