Cleared Traditional

MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER (K011392) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

Submission Details

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.

Device Classification

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 61
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