FDA product code HPL: Device, Fixation, Ac-Powered, Ophthalmic
HPL is the FDA product code for device, fixation, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1290 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HPL, from 7 different applicants. The average 510(k) review took 157 days (median 77).
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.)
Classification
| Field | Value |
|---|---|
| Device name | Device, Fixation, Ac-Powered, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1290 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPL clearance
Top HPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Storz Instrument Co. | 1 | 1994-08-29 |
| Varitronics | 1 | 1994-03-14 |
| Richmond Products, Inc. | 1 | 1987-12-11 |
| Carl Zeiss, Inc. | 1 | 1985-11-12 |
| Fite Engineering Corp. | 1 | 1980-07-28 |
2 more applicants have HPL clearances. See the full list in Caduvo.
Most recent HPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931731 | Storz Instrument Co. | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY | 1994-08-29 | 509 |
| K933739 | Varitronics | 360 DEGREE FIXATION LIGHT | 1994-03-14 | 223 |
| K873914 | Richmond Products, Inc. | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | 1987-12-11 | 77 |
| K854383 | Carl Zeiss, Inc. | KERATOLUX | 1985-11-12 | 13 |
| K801381 | Fite Engineering Corp. | FITE FIXATION TOY FOR OCULAR EXAM | 1980-07-28 | 47 |
Recalls for HPL devices
openFDA lists no recalls for product code HPL.
Frequently asked questions
What is FDA product code HPL?
HPL is the FDA product code for device, fixation, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1290 and reviewed by the Ophthalmic panel.
What device class is HPL?
Class I, regulation 21 CFR 886.1290. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPL?
Across 7 cleared submissions the average was 157 days from receipt to decision (median 77).
Which companies have the most HPL clearances?
Storz Instrument Co. (1); Varitronics (1); Richmond Products, Inc. (1); Carl Zeiss, Inc. (1); Fite Engineering Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPL
- Run a recall and safety report across every HPL manufacturer
- Watch product code HPL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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