HPL — Device, Fixation, Ac-Powered, Ophthalmic Class I
Classification Details
- Product Code
- HPL
- Device Class
- Class I
- Regulation Number
- 886.1290
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K931731 | storz instrument | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY | August 29, 1994 |
| K933739 | varitronics | 360 DEGREE FIXATION LIGHT | March 14, 1994 |
| K873914 | richmond products | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | December 11, 1987 |
| K854383 | carl zeiss | KERATOLUX | November 12, 1985 |
| K801381 | fite engineering | FITE FIXATION TOY FOR OCULAR EXAM | July 28, 1980 |
| K800112 | life-tech instruments | AMBLYOPIA TRAINER | March 10, 1980 |
| K781313 | clement clarke | VISION-STIMULATOR, CAM | January 26, 1979 |