HPL
7 FDA 510(k) clearances · Product code
77 daysmedian time to decision
509 days90th percentile
7clearances measured
FDA profile
- Official device name
- Device, Fixation, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1290
- Medical specialty
- 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.)
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY (K931731) | Storz Instrument Co. | 1994-08-29 |
| 360 DEGREE FIXATION LIGHT (K933739) | Varitronics | 1994-03-14 |
| ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (K873914) | Richmond Products, Inc. | 1987-12-11 |
| KERATOLUX (K854383) | Carl Zeiss, Inc. | 1985-11-12 |
| FITE FIXATION TOY FOR OCULAR EXAM (K801381) | Fite Engineering Corp. | 1980-07-28 |
| AMBLYOPIA TRAINER (K800112) | Life-Tech Instruments, Inc. | 1980-03-10 |
| VISION-STIMULATOR, CAM (K781313) | Clement Clarke, Inc. | 1979-01-26 |
Track HPL automatically
Every clearance here is in the API, with alerts when new ones post.