ENFOCUS 2300 INTEGRATED OCT

GUDID 00857691006039

BIOPTIGEN, INC.

Ophthalmic spectral-domain optical coherence tomography system

• Primary Device ID: 00857691006039
• NIH Device Record Key: 8eb09b93-4a17-46d0-a67d-537a476a6390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFOCUS 2300 INTEGRATED OCT
• Version Model Number: 900C23550V5
• Company DUNS: 361420040
• Company Name: BIOPTIGEN, 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(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(919)595-1274
• Email: Iris.Pohl@leica-microsystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857691006039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162783

FDA Product Code

• OBO: Tomography, optical coherence

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: 2024-05-10
• Device Publish Date: 2024-05-02

Devices Manufactured by BIOPTIGEN, INC.

• 00857691006039 - ENFOCUS 2300 INTEGRATED OCT: 2024-05-10
• 00857691006039 - ENFOCUS 2300 INTEGRATED OCT: 2024-05-10
• 00857691006336 - ENFOCUS 2300 VHR 100V: 2020-12-01
• 00857691006343 - ENFOCUS 4400 VHR 100V: 2020-12-01
• 00857691006022 - ENVISU C2300 VHR 120V: 2018-07-06
• 00857691006053 - ENVISU C2300 VHR 220V: 2018-07-06
• 00857691006084 - ENFOCUS C2300 VHR 120V: 2018-07-06
• 00857691006091 - ENFOCUS C2300 VHR 220V: 2018-07-06
• 00857691006107 - ENFOCUS C4400 HR 120V: 2018-07-06