Optomed Smartscope FA

GUDID 06430046261006

Optomed Smartscope FA optic module

Optomed Oy

Multi-purpose digital medical camera lens, intraocular, fluorescent angiography

• Primary Device ID: 06430046261006
• NIH Device Record Key: 4bde4aab-b944-47fd-818b-ca8c4807ae73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optomed Smartscope FA
• Version Model Number: 41000040
• Company DUNS: 401968495
• Company Name: Optomed Oy
• 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: false
• 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	06430046261006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201325

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: 2025-12-22
• Device Publish Date: 2025-12-12

Devices Manufactured by Optomed Oy

• 06430046261006 - Optomed Smartscope FA: 2025-12-22Optomed Smartscope FA optic module
• 06430046261006 - Optomed Smartscope FA: 2025-12-22 Optomed Smartscope FA optic module
• 06430046260597 - Smartscope Pro full set: 2025-11-21 Optomed Smartscope Pro full set M5WEY4ES2
• 06430046260689 - Smartscope Pro retinal set: 2025-11-21 Optomed Smartscope Pro retinal set M5WEY4
• 06430046260993 - Optomed Lumo Camera set: 2025-11-21 Optomed Lumo Camera set
• 06430046260658 - Pictor M5WEY4ES2 Volk FN: 2021-11-23 Volk Pictor Plus full set
• 06430046260672 - Pictor M5WEY4 Volk FN: 2021-11-23 Volk Pictor Plus retinal set
• 06430046260757 - Optomed Aurora full set: 2019-12-12 Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
• 06430046260795 - Optomed Aurora retinal set: 2019-12-12 Optomed Aurora retinal set including Aurora camera and Aurora retinal module.