ILUMIEN™ OPTIS™ to OPTIS™ UIMG901003

GUDID 05415067053879

Mobile Next Direct Upgrade Accessory Kit

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system

• Primary Device ID: 05415067053879
• NIH Device Record Key: 694bb567-01bd-468a-9522-7cf3f77c32dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILUMIEN™ OPTIS™ to OPTIS™
• Version Model Number: UIMG901003
• Catalog Number: UIMG901003
• Company DUNS: 018493531
• Company Name: LIGHTLAB IMAGING, INC.
• 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Excursions are permitted between -20°C and 50°C (-4°F and 122°F) and Humidity limitation from 25% to 90%

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067053879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210458

FDA Product Code

• NQQ: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-08
• Device Publish Date: 2025-07-31

Devices Manufactured by LIGHTLAB IMAGING, INC.

• 05415067053879 - ILUMIEN™ OPTIS™ to OPTIS™: 2025-08-08Mobile Next Direct Upgrade Accessory Kit
• 05415067053879 - ILUMIEN™ OPTIS™ to OPTIS™: 2025-08-08 Mobile Next Direct Upgrade Accessory Kit
• 05415067047694 - Ultreon™: 2024-04-08 2.0 Software Upgrade Kit
• 05415067048882 - AptiVue™: 2023-10-09 Imaging Software Upgrade Kit
• 05415067030856 - AptiVue™: 2020-11-03 Software Upgrade Kit
• 00183739000678 - ILUMIEN™: 2019-02-11 Imaging System
• 00183739000937 - OPTIS™: 2019-02-11 Imaging System
• 00812059021420 - OPTIS™: 2019-02-11 Imaging System
• 00183739000562 - C7 Dragonfly™: 2018-03-29 Imaging Catheter