# Manual Refractor, 3d Display
> **Product code: SBI** · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1770
## Classification
- **FDA Product Code:** SBI
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 886.1770
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SBI)
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