K781313 is an FDA 510(k) clearance for the VISION-STIMULATOR, CAM. This device is classified as a Device, Fixation, Ac-powered, Ophthalmic (Class I - General Controls, product code HPL).
Submitted by Clement Clarke, Inc.. The FDA issued a Cleared decision on January 26, 1979, 179 days after receiving the submission on July 31, 1978.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1290. A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.).
| 510(k) Number | K781313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1978 |
| Decision Date | January 26, 1979 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPL — Device, Fixation, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1290 |
| Definition | A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.) |