# Device, Fixation, Ac-Powered, Ophthalmic
> **Product code: HPL** · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1290
## Classification
- **FDA Product Code:** HPL
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 886.1290
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.)

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=HPL)
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