Q-Switched Nd:YAG Disposable Tips Spot size 3.5mm

GUDID 07290117770368

LUMENIS BE LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290117770368
• NIH Device Record Key: 13bb3cc3-dd04-4d0c-ab53-39bfde789bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Switched Nd:YAG Disposable Tips Spot size 3.5mm
• Version Model Number: Q-Switched Nd:YAG Disposable Tips Spot size 3.5mm
• 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	07290117770368 [Unit of Use]
GS1	17290117770655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193500

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: 2023-08-10
• Device Publish Date: 2023-08-02

Devices Manufactured by LUMENIS BE LTD

• 07290117772645 - Black Stellar XPL HP: 2025-09-16
• 07290117772652 - Stellar XPL Module Kit: 2025-09-16
• 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