# Conformer, Ophthalmic, Biological Tissue
> **Product code: NQB** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3130
## Classification
- **FDA Product Code:** NQB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.3130
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQB)
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