HPLClass I
Device, Fixation, Ac-Powered, Ophthalmic
21 CFR 886.1290 / Ophthalmic
HPL is the FDA product code for Device, Fixation, Ac-Powered, Ophthalmic, a class I device type, regulated under 21 CFR 886.1290. FDA's definition for this code reads: "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.)". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HPL
- Device name
- Device, Fixation, Ac-Powered, Ophthalmic
- FDA 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.)
- Regulation
- 21 CFR 886.1290
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code HPL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 2 |
| 1985 | 1 |
| 1987 | 1 |
| 1994 | 2 |
Applicants with the most clearances
Product code HPL| Applicant | Clearances |
|---|---|
| Carl Zeiss, Inc. | 1 |
| Clement Clarke, Inc. | 1 |
| Fite Engineering Corp. | 1 |
| Life-Tech Instruments, Inc. | 1 |
| Richmond Products, Inc. | 1 |
| Storz Instrument Co. | 1 |
| Varitronics | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.