AcPulse W

GUDID 07290117771389

LUMENIS BE LTD

General/multiple surgical carbon dioxide laser system

• Primary Device ID: 07290117771389
• NIH Device Record Key: e9eae5e8-a8e4-4723-bc3e-2369a0ea3195
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcPulse W
• 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	07290117771389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202428

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: 2023-12-12
• Device Publish Date: 2023-12-04

Devices Manufactured by LUMENIS BE LTD

• 07290117772737 - Multi-Spot™ Nd:YAG Head: 2025-12-29
• 07290117772744 - M22™ Q-Switched Head: 2025-12-29
• 07290117772751 - Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kit: 2025-12-29
• 07290117772768 - Stellar M22™ Q-Switched Nd:YAG Upgrade Kit: 2025-12-29
• 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