Cleared Traditional

iPrime Viscodelivery System

K212797 · Glaukos · Ophthalmic
Jan 2022
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K212797 is an FDA 510(k) clearance for the iPrime Viscodelivery System, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Glaukos (San Clemente, US). The FDA issued a Cleared decision on January 6, 2022, 126 days after receiving the submission on September 2, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K212797 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2021
Decision Date January 06, 2022
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRH — Pump, Infusion, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725