# Shell, Scleral
> **Product code: HQT** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3800
## Classification
- **FDA Product Code:** HQT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.3800
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=HQT)
---
*AI Analytics · CC0 1.0*