Molteno3 Glaucoma Implant— 510(k) K152996

Name: FDA 510(k) clearance K152996
Creator: U.S. Food and Drug Administration
Published: 2015-12-17

Substantially Equivalent

Innovative Ophthalmic Products, Inc. (Iop)

FDA 510(k) clearance K152996 for Molteno3 Glaucoma Implant, Substantially Equivalent on 2015-12-17. Applicant: Innovative Ophthalmic Products, Inc. (Iop). Device class: 2.

Clearance details

Applicant: Innovative Ophthalmic Products, Inc. (Iop)
Product code: Code KYF
Device class: Class 2
Regulation: 21 CFR 886.3920
Advisory panel: Ophthalmic
Date received: 2015-10-13
Decision date: 2015-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYF

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K230975 — Ahmed® Glaucoma Valve Model FP72023-05-12
K231051 — Ahmed® Glaucoma Valve Model FP82023-05-12
K220032 — iStent infinite Trabecular Micro-Bypass System, Model iS32022-08-02
K182518 — AHMED ClearPath Glaucoma Drainage Device2019-01-18
K171451 — Ahmed Glaucoma Valve Model FP82017-08-08

Adverse events under product code KYF

product code KYF

Injury: 1,543
Malfunction: 646
Total: 2,189

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.