EdgePro 7210002

GUDID 00647529004135

An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

Dental solid-state laser system

• Primary Device ID: 00647529004135
• NIH Device Record Key: 787f1768-3e9f-42db-8ed6-7214549f18aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgePro
• Version Model Number: EdgePro Laser System (Juno)
• Catalog Number: 7210002
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529004135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213428

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

Moist Heat or Steam Sterilization

[00647529004135]

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

On-Brand Devices [EdgePro]

• 00647529004296: A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
• 00647529004241: A reusable handpiece intended for use with the EdgePro Laser System (Juno) in a variety of denta
• 00647529004135: An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue pro
• 00647529004326: A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
• 00647529003572: A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
• 00647529004180: A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
• 00647529003589: A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
• 00647529004319: A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).