IRLightSurgN

GUDID G465100200

LED & Laser Light Source

Smartsurgn Inc.

Endoscopic video image processing/light source system

• Primary Device ID: G465100200
• NIH Device Record Key: c590286e-33a6-4495-84b0-f7e99c877140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRLightSurgN
• Version Model Number: 10020
• Company DUNS: 115617378
• Company Name: Smartsurgn 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G465100200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213943

FDA Product Code

• OWN: Confocal Optical Imaging

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: 2023-10-24
• Device Publish Date: 2023-10-16

Devices Manufactured by Smartsurgn Inc.

• G465FG12000 - Non-ICG 4mm Sinuscope (70 Deg): 2025-09-04 Non-ICG 4mm Sinuscope (70 Deg)
• G465FG14000 - Non-ICG 4mm Sinuscope (30 Deg): 2025-09-04 Non-ICG 4mm Sinuscope (30 Deg)
• G465FG15000 - Non-ICG 4mm Sinuscope (0 Deg): 2025-09-04 Non-ICG 4mm Sinuscope (0 Deg)
• G465FG16000 - Non-ICG 5mm Laparoscope (0 Deg): 2025-09-04 Non-ICG 5mm Laparoscope (0 Deg)
• G465FG17000 - Non-ICG 5mm Laparoscope (30 Deg): 2025-09-04 Non-ICG 5mm Laparoscope (30 Deg)
• G465100300 - AirSurgN Insufflator: 2025-04-30 AirSurgN Insufflator
• G465FG1800 - Monitor 55 Inch: 2025-03-21 4K Monitor 55 Inch
• G465FG13240 - Light Cable: 2024-07-25 Schott Fiber Optic Light Cable