High-Speed (HS) Disposables KIT

GUDID 07290117770733

LUMENIS BE LTD

Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system

• Primary Device ID: 07290117770733
• NIH Device Record Key: 1b9331a2-f8a1-475b-b8ef-728be4e4d95d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High-Speed (HS) Disposables KIT
• Version Model Number: High-Speed (HS) Disposables KIT
• Company DUNS: 600763501
• Company Name: LUMENIS BE LTD
• Device Count: 30
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117770733 [Unit of Use]
GS1	17290117770730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170179

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-18
• Device Publish Date: 2023-08-10

Devices Manufactured by LUMENIS BE LTD

• 07290117772447 - FoLiCool™ Tip: 2024-03-25
• 07290117772522 - FoLix™: 2024-03-25
• 07290117772539 - FoLix™ Handpiece: 2024-03-25
• 07290117772393 - LUSTER System: 2024-01-30
• 07290117772409 - LUSTER Handpiece: 2024-01-30
• 07290117772416 - LUSTER Tip, Round: 2024-01-30
• 17290117772420 - OPT™ Shields: 2024-01-03
• 07290117771372 - AcuPulse: 2023-12-12