Optain

GUDID 00860014304507

The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

Optain Health, Inc.

Ophthalmic fundus camera

• Primary Device ID: 00860014304507
• NIH Device Record Key: c048d5ec-e42d-4ca4-9aef-8543c80a9d11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optain
• Version Model Number: Resolve Fundus Camera
• Company DUNS: 119517299
• Company Name: Optain Health, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00860014304507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250683

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: 2025-07-15
• Device Publish Date: 2025-07-07