Cleared Traditional

K024164 - COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT

K024164 is an FDA 510(k) clearance for COMFORTKONE KERATOCONUS ASPHERIC (HYBUF..., manufactured by Metro Optics, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K024164 · Metro Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
57d
Days
Class 2
Risk

K024164 is an FDA 510(k) clearance for the COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIG.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Metro Optics, Inc. (Grand Junction, US). The FDA issued a Cleared decision on February 12, 2003 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 Metro Optics, Inc. devices

FDA 510(k) Submission Details - K024164

510(k) Number K024164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2002
Decision Date February 12, 2003
Days to Decision 57 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
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 75
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K024164.
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