Cleared Traditional

K011392 - MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER

K011392 is an FDA 510(k) clearance for MICRA LENS INJECTOR, manufactured by Micra Instruments. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K011392 · Micra Instruments · Ophthalmic device
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Oct 2001
Decision
168d
Days
Class 1
Risk

K011392 is an FDA 510(k) clearance for the MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Micra Instruments (Luton, Bedfordshire, GB). The FDA issued a Cleared decision on October 22, 2001 after a review of 168 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Micra Instruments devices

FDA 510(k) Submission Details - K011392

510(k) Number K011392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date October 22, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 110d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 42
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K011392.
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MONARCH II IOL DELIVERY SYSTEM
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