OPTICAL BIOMETER

GUDID 04573344510024

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography (SS-OCT). The device is intended to acquire ocular measurements as well asperform calculations to determine the appropriate intraocular lens (IOL) power and typefor implantation during intraocular lens placement. ARGOS measures the following 9parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness,K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-white(corneal diameter) and Pupil Size. The Reference Image functionality is intended for useas a preoperative and postoperative image capture tool.It is intended for use by ophthalmologists, physicians, and other eye-care professionalsand may only be used under the supervision of a physician.

SANTEC CORPORATION

Keratometer

• Primary Device ID: 04573344510024
• NIH Device Record Key: b70b121c-2629-4ea0-8645-86b498a98e83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTICAL BIOMETER
• Version Model Number: ARGOS ver1.5
• Company DUNS: 704295641
• Company Name: SANTEC CORPORATION
• 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	04573344510024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191051

FDA Product Code

• MXK: Device, Analysis, Anterior Segment

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: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [OPTICAL BIOMETER]

• 04573344510017: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography
• 04573344510024: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography