iLase Handpiece

GUDID 00647529002308

iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of dental soft-tissue procedures such as incision, excision, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, as well as laser periodontal procedures. The laser has a wavelength of 940nm. The laser energy is delivered to the treatment site via a single-use laser tip attached to the handpiece. The handpiece is reusable with a removable cover which requires sterilization prior to each patient use. The iLase packaging contains one handpiece and accessories such as laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips. The product is also available as a system packaged with a charging station which is used for charging and storing the iLase and replacement batteries.

BIOLASE, INC.

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• Primary Device ID: 00647529002308
• NIH Device Record Key: 9675cf05-1923-437f-80c8-901c84e4f274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLase Handpiece
• Version Model Number: iLase
• 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: true
• 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	00647529002292 [Primary]
GS1	00647529002308 [Package]; Contains: 00647529002292; Package: Case [1 Units]; In Commercial Distribution

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

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

Moist Heat or Steam Sterilization

[00647529002308]

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 Handpiece ]

• 00647529002551: iLase Handpiece is a diode laser handpiece designed for a variety of dental soft tissue procedur
• 00647529002308: iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of