HPL · Device, Fixation, Ac-Powered, Ophthalmic
Ophthalmic · 21 CFR 886.1290 · Class 1
Overview
| Product Code | HPL |
|---|---|
| Device Name | Device, Fixation, Ac-Powered, Ophthalmic |
| Regulation | 21 CFR 886.1290 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological 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.)
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931731 | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY | Storz Instrument Co. | Aug 29, 1994 | SESE |
| K933739 | 360 DEGREE FIXATION LIGHT | Varitronics | Mar 14, 1994 | SESE |
| K873914 | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | Dec 11, 1987 | SESE |
| K854383 | KERATOLUX | Carl Zeiss, Inc. | Nov 12, 1985 | SESE |
| K801381 | FITE FIXATION TOY FOR OCULAR EXAM | Fite Engineering Corp. | Jul 28, 1980 | SESE |
| K800112 | AMBLYOPIA TRAINER | Life-Tech Instruments, Inc. | Mar 10, 1980 | SESE |
| K781313 | VISION-STIMULATOR, CAM | Clement Clarke, Inc. | Jan 26, 1979 | SESE |
Top Applicants
- Carl Zeiss, Inc. — 1 clearance
- Clement Clarke, Inc. — 1 clearance
- Fite Engineering Corp. — 1 clearance
- Life-Tech Instruments, Inc. — 1 clearance
- Richmond Products, Inc. — 1 clearance
