Focused Incisional Handpiece Set

GUDID 07290117771693

Direct Marking (DM): 07290117772102, 07290117772119, 07290117772133, 07290117772126.

LUMENIS BE LTD

Surgical laser system beam-focus handpiece

• Primary Device ID: 07290117771693
• NIH Device Record Key: 640c4c96-f15e-407f-936f-ae65d3eb8fa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focused Incisional Handpiece Set
• Version Model Number: NA
• 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	07290117771693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030147

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

[07290117771693]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-12
• Device Publish Date: 2023-12-04

On-Brand Devices [Focused Incisional Handpiece Set]

• 07290117771709: Direct Marking (DM): 07290117772102, 07290117772119, 07290117772133, 07290117772126.
• 07290117771693: Direct Marking (DM): 07290117772102, 07290117772119, 07290117772133, 07290117772126.