K854383 is an FDA 510(k) clearance for the KERATOLUX. This device is classified as a Device, Fixation, Ac-powered, Ophthalmic (Class I - General Controls, product code HPL).
Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on November 12, 1985, 13 days after receiving the submission on October 30, 1985.
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 | K854383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1985 |
| Decision Date | November 12, 1985 |
| Days to Decision | 13 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.) |