Device, Fixation, Ac-Powered, Ophthalmic
An AC-Powered Ophthalmic Fixation Device is an electrically powered device used as a fixation target for patients during ophthalmologic examination. The patient directs their gaze so that the visual image of the fixation object falls on the fovea centralis, the center of the macular retina of the eye, helping to stabilize gaze during diagnostic testing. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket submission. It carries product code HPL and is regulated under 21 CFR 886.1290, within the Ophthalmic medical specialty.
Research product code HPL in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HPL
- Device Class
- FDA class 1
- Regulation Number
- 886.1290
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.)
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931731 | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY | Aug 29, 1994 | Substantially Equivalent | Storz Instrument Co. |
| K933739 | 360 DEGREE FIXATION LIGHT | Mar 14, 1994 | Substantially Equivalent | Varitronics |
| K873914 | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | Dec 11, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K854383 | KERATOLUX | Nov 12, 1985 | Substantially Equivalent | Carl Zeiss, Inc. |
| K801381 | FITE FIXATION TOY FOR OCULAR EXAM | Jul 28, 1980 | Substantially Equivalent | Fite Engineering Corp. |
| K800112 | AMBLYOPIA TRAINER | Mar 10, 1980 | Substantially Equivalent | Life-Tech Instruments, Inc. |
| K781313 | VISION-STIMULATOR, CAM | Jan 26, 1979 | Substantially Equivalent | Clement Clarke, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.