Cleared Traditional

K062252 - MOLTENO3

K062252 is an FDA 510(k) clearance for MOLTENO3, manufactured by Iop, Inc.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K062252 · Iop, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
55d
Days
Class 2
Risk

K062252 is an FDA 510(k) clearance for the MOLTENO3. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on September 27, 2006 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iop, Inc. devices

FDA 510(k) Submission Details - K062252

510(k) Number K062252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2006
Decision Date September 27, 2006
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 110d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYF Device Classification - Class 2, Special Controls

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - KYF Implant, Eye Valve

All 14
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K062252.
XEN Glaucoma Treatment System
K161457 · Allergan, Inc. · Nov 2016
Ahmed Glaucoma Valve
K162060 · New World Medical, Inc. · Oct 2016
Molteno3 Glaucoma Implant
K152996 · Innovative Ophthalmic Products, Inc. (Iop) · Dec 2015
AHMED GLAUCOMA VALVE IMPLANT
K991072 · New World Medical, Inc. · Jul 1999
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · Pharmacia Iovision, Inc. · Feb 1997