TrueSpot™ 2.0mm Handpiece

GUDID 07290117771679

LUMENIS BE LTD

Surgical laser system beam-focus handpiece

• Primary Device ID: 07290117771679
• NIH Device Record Key: a2cdc8d0-92c9-4778-8abf-8cc3239d5bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueSpot™ 2.0mm Handpiece
• 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	07290117771679 [Primary]
GS1	07290117772140 [Direct Marking]

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

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

Moist Heat or Steam Sterilization

[07290117771679]

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 [TrueSpot™ 2.0mm Handpiece]

• 07290117771686: NA
• 07290117771679: NA