OPTICAL BIOMETER
Basic Information
- Brand Name
- OPTICAL BIOMETER
- Primary DI
- 04573344510024
- Version / Model
- ARGOS ver1.5
- Company Name
- SANTEC CORPORATION
- Labeler DUNS
- 704295641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-22
- Public Version
- 2
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- b70b121c-2629-4ea0-8645-86b498a98e83
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | Ophthalmic | 886.1850 | 2 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12811 | Bench-top keratometer | A bench-top, mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04573344510024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191051 | 000 |