Waterlase MDX 450 Laser System 7200860-06

GUDID 00647529000304

An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use.

BIOLASE, INC.

Dental solid-state laser system

• Primary Device ID: 00647529000304
• NIH Device Record Key: c3993e11-127d-447d-ae68-40593da97134
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waterlase MDX 450 Laser System
• Version Model Number: 7200860-06
• Catalog Number: 7200860-06
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529000304 [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

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

Moist Heat or Steam Sterilization

[00647529000304]

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 MDX 450 Laser System ]

• 00647529002506: An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedur
• 00647529000304: An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedur
• 00647529003282: An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedur