Ophthalmic Syringe

QLY · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5860

Classification

FDA Product Code: QLY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5860
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 6

Source

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