EdgePro 6200181

GUDID 00647529003589

A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).

Biolase, Inc.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00647529003589
• NIH Device Record Key: 84663439-0519-4e86-9387-164ac6357129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgePro
• Version Model Number: Tip Assembly - Two-17mm, WL JUNO
• Catalog Number: 6200181
• Company DUNS: 152165700
• Company Name: Biolase, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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 Dimensions

• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer
• Length: 17 Millimeter
• Outer Diameter: 320 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529003589 [Package]; Contains: 00647529004081; Package: Box [10 Units]; In Commercial Distribution
GS1	00647529004081 [Primary]
GS1	00647529004210 [Package]; Contains: 00647529004081; Package: Box [30 Units]; In Commercial Distribution

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

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

Moist Heat or Steam Sterilization

[00647529003589]

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).