MOLTENO3— 510(k) K062252

Name: FDA 510(k) clearance K062252
Creator: U.S. Food and Drug Administration
Published: 2006-09-27

Substantially Equivalent

Iop, Inc.

FDA 510(k) clearance K062252 for MOLTENO3, Substantially Equivalent on 2006-09-27. Applicant: Iop, Inc.. Device class: 2.

Clearance details

Applicant: Iop, Inc.
Product code: Code KYF
Device class: Class 2
Regulation: 21 CFR 886.3920
Advisory panel: Ophthalmic
Date received: 2006-08-03
Decision date: 2006-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K062252

K-number listed on FDA's recall record

Z-1252-2016 — Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)Class II·Terminated·Innovative Ophthalmic Products, Inc·20160222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062252.

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