Applicator, Negative Pressure, External, Ocular

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown