Cleared Traditional

K020006 - DYNA INTRA-LIMBAL LENS

K020006 is an FDA 510(k) clearance for DYNA INTRA-LIMBAL LENS, manufactured by Lens Dynamics, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K020006 · Lens Dynamics, Inc. · Ophthalmic device
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Mar 2002
Decision
86d
Days
Class 2
Risk

K020006 is an FDA 510(k) clearance for the DYNA INTRA-LIMBAL LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Lens Dynamics, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 29, 2002 after a review of 86 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 Lens Dynamics, Inc. devices

FDA 510(k) Submission Details - K020006

510(k) Number K020006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2002
Decision Date March 29, 2002
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 78
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K020006.
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RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · Polymer Technology Corp. · Sep 2001
SPORTSIGHT GP
K993586 · Paragon Vision Sciences · May 2000
MENICON SF-P
K000233 · Menicon Co, Ltd. · May 2000