FDA UDI
In Commercial Distribution
🇺🇸 United States
SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM Chronos
DI: 04560126268662
·
Model: SNi-1
·
TOPCON CORPORATION
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM Chronos
- Primary DI
- 04560126268662
- Version / Model
- SNi-1
- Company Name
- TOPCON CORPORATION
- Labeler DUNS
- 690542881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-01
- Public Version
- 1
- Public Version Date
- 2025-05-09
- Public Version Status
- New
- Public Device Record Key
- 1aae4aff-9845-477d-8459-ad6c3c341c85
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | Ophthalmic | 886.1770 | 1 |
| HKO | Refractometer, Ophthalmic | Ophthalmic | 886.1760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36386 | Automated ophthalmic refractometer | An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision. | No | Active |
| 66910 | Phoropter, electric | An electrically-powered ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as an automated or digital refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist changes the lenses and other settings via an electrical control unit, while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04560126268662 | GS1 |