K933739 is an FDA 510(k) clearance for the 360 DEGREE FIXATION LIGHT. This device is classified as a Device, Fixation, Ac-powered, Ophthalmic (Class I - General Controls, product code HPL).
Submitted by Varitronics (Broomall, US). The FDA issued a Cleared decision on March 14, 1994, 223 days after receiving the submission on August 3, 1993.
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 | K933739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1993 |
| Decision Date | March 14, 1994 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| 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.) |