Nd:YAG SapphireCool™ Lightguides 2x4mm Kit

GUDID 07290117770535

LUMENIS BE LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290117770535
• NIH Device Record Key: 5e871d99-bd5c-4a6c-ba65-d0431f27bf11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nd:YAG SapphireCool™ Lightguides 2x4mm Kit
• Version Model Number: Nd:YAG SapphireCool™ Lightguides 2x4mm Kit
• Company DUNS: 600763501
• Company Name: LUMENIS BE LTD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117770535 [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

• 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