Laser Engineering 1059746

GUDID 00860011139706

Re-usable fiberoptic handpiece for lasers

LASER ENGINEERING

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00860011139706
• NIH Device Record Key: d4a69dc3-df52-4434-a293-860b0433fe7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Engineering
• Version Model Number: OTO Handpiece
• Catalog Number: 1059746
• Company DUNS: 028541358
• Company Name: LASER ENGINEERING
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011139706 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

[00860011139706]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-19
• Device Publish Date: 2024-04-11

Devices Manufactured by LASER ENGINEERING

• 00860011139706 - Laser Engineering: 2024-04-19Re-usable fiberoptic handpiece for lasers
• 00860011139706 - Laser Engineering: 2024-04-19 Re-usable fiberoptic handpiece for lasers
• 10866988000213 - UltraLase Flexible Laser Waveguide: 2021-11-16 This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
• 10866988000268 - UltraLase Flexible Laser Waveguide: 2020-03-31 This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
• 10866988000237 - Imperium: 2019-01-31 CO2 Laser Waveguide - 500 microns
• 00866988000247 - Imperium: 2019-01-31 CO2 Laser Waveguide - 300 microns
• 00866988000209 - UltraLase Flexible Laser Waveguide: 2018-07-06 This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient
• 00866988000223 - UltraLase Flexible Laser Waveguide: 2018-03-29 This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.