Cleared Traditional

K002279 - ML EYE SPEAR, MODEL ML 27 ES

K002279 is an FDA 510(k) clearance for ML EYE SPEAR, manufactured by Med-Logics, Inc.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K002279 · Med-Logics, Inc. · Ophthalmic device
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Aug 2000
Decision
23d
Days
Class 2
Risk

K002279 is an FDA 510(k) clearance for the ML EYE SPEAR, MODEL ML 27 ES. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Med-Logics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on August 18, 2000 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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.

FDA 510(k) Submission Details - K002279

510(k) Number K002279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2000
Decision Date August 18, 2000
Days to Decision 23 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 110d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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 - HOZ Sponge, Ophthalmic

All 39
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K002279.
ULTRACELL ABSORBENT STICK
K012196 · Ultracell Medical Technologies, Inc. · Aug 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
PRESCOTT'S SURGICAL SPEAR
K003842 · Prescott'S, Inc. · Apr 2001
M-PACT CORNEAL LIGHT SHIELD
K993883 · M-Pact Corp. · Dec 1999
DRAINAGE WICK
K990671 · Hurricane Medical · May 1999
SOF-SUCTION FLUID EVACUATION SYSTEM
K990749 · X-Tech Medical, LLC · Apr 1999
K002279 · ML EYE SPEAR, MODEL ML 27 ES
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