UltraPulse Focused Incisional HandPiece set

GUDID 07290109144511

Additional DM UDI: 07290109144528

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system

• Primary Device ID: 07290109144511
• NIH Device Record Key: 2fe48f55-20b7-4ff1-a3ab-fc4a2728d8f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraPulse Focused Incisional HandPiece set
• Version Model Number: UltraPulse Focused Incisional HandPiece set
• Company DUNS: 600166524
• Company Name: LUMENIS 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	07290109144511 [Direct Marking]
GS1	07290109145075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203544

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290109144511]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-21
• Device Publish Date: 2021-01-13

Devices Manufactured by LUMENIS LTD.

• 07290109147161 - Lumenis Pulse 120H: 2025-02-26
• 07290109147178 - Lumenis Pulse 120H: 2025-02-26
• 07290109147185 - Lumenis Pulse, Moses 2.0 (DOM): 2025-02-26
• 07290109147192 - Lumenis Pulse 120H: 2025-02-26
• 07290109147208 - Lumenis Pulse, Moses 2.0 (INT): 2025-02-26
• 07290109147215 - Lumenis Pulse 120H: 2025-02-26
• 07290109147222 - Lumenis Pulse 120H: 2025-02-26
• 07290109147291 - Lumenis Pulse 120H: 2025-02-26