Stellar Optima Treatment Kit

GUDID 17290109145126

LUMENIS LTD.

Intense pulsed light dry eye therapy unit

• Primary Device ID: 17290109145126
• NIH Device Record Key: 90e29ad9-cca0-4347-945e-9e8e72d37b75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stellar Optima Treatment Kit
• Version Model Number: Stellar Optima Treatment Kit
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	07290109145129 [Primary]
GS1	17290109145126 [Package]; Contains: 07290109145129; Package: [48 Units]; In Commercial Distribution

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: 2021-04-21
• Device Publish Date: 2021-04-13

Devices Manufactured by LUMENIS LTD.

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• 07290109144924 - Stellar SapphireCool LG 6mm: 2023-08-16
• 07290109144931 - Stellar SapphireCool LG 15x35: 2023-08-16
• 07290109144948 - Stellar SapphireCool LG 8x15: 2023-08-16
• 07290109146676 - SurgiTouch Scanner: 2022-09-30
• 07290109146133 - UltraPulse® DUO: 2022-09-28 UltraPulse DUO
• 07290109147055 - VersaPulse PowerSuite 80/100W: 2022-09-27
• 07290109147062 - VersaPulse PowerSuite 80/100W: 2022-09-27