# Applicator, Negative Pressure, External, Ocular
> **Product code: QQJ** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5000
## Classification
- **FDA Product Code:** QQJ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.5000
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QQJ)
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