# Table, Instrument, Manual, Ophthalmic
> **Product code: HRK** · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4855
## Classification
- **FDA Product Code:** HRK
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 886.4855
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** Y
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 13
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=HRK)
---
*AI Analytics · CC0 1.0*