OptiLight™ Aesthetics

GUDID 07290117771006

LUMENIS BE LTD

Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit

• Primary Device ID: 07290117771006
• NIH Device Record Key: efa597d5-6cda-49b1-894b-874b7fd84447
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiLight™ Aesthetics
• Version Model Number: OptiLight Aesthetics
• 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	07290117771006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200028

FDA Product Code

• QIU: Intense Pulsed Light Device For Managing Dry Eye

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: 2022-08-18
• Device Publish Date: 2022-08-10

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