Neolight

GUDID 00852788008026

FA Module

NEOLIGHT LLC

Ophthalmic fundus camera

• Primary Device ID: 00852788008026
• NIH Device Record Key: a2148ad4-f481-40d2-9bde-234054b2ed3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neolight
• Version Model Number: PCI 40-1004
• Company DUNS: 074301687
• Company Name: NEOLIGHT LLC
• 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	00852788008026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223575

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2025-02-03
• Device Publish Date: 2025-01-26

On-Brand Devices [Neolight]

• 20852788008051: ICON GO & FA
• 20852788008044: ICON GO
• 20852788008037: ICON Cart
• 20852788008020: ICON Cart & FA
• 10852788008085: ICON Handpiece
• 00852788008071: White Light Module
• 00852788008064: ICON Footswitch
• 00852788008057: ICON GO Control Box
• 00852788008040: Diffuser
• 00852788008026: FA Module
• 00852788008019: ICON Cart Control Box