iLase Diode Laser System

GUDID 00647529001332

A diode laser system designed for a variety of dental soft tissue procedures. The system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, diode laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use.

BIOLASE, INC.

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• Primary Device ID: 00647529001332
• NIH Device Record Key: 95694eb3-f4a3-4c32-9fe2-5de1a221dd49
• Commercial Distribution Discontinuation: 2018-09-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iLase Diode Laser System
• Version Model Number: iLase 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: 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: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529001332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093852

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

[00647529001332]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-22

On-Brand Devices [iLase Diode Laser System]

• 00647529002322: iLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase
• 00647529001332: A diode laser system designed for a variety of dental soft tissue procedures. The system consis