Cleared Traditional

RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY (K992589) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992589 · Opti-Centre Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
24d
Days
Class 2
Risk

K992589 is an FDA 510(k) clearance for the RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY .... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Opti-Centre Laboratories (Grand Junction, US). The FDA issued a Cleared decision on August 26, 1999 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Opti-Centre Laboratories devices

Submission Details

510(k) Number K992589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date August 26, 1999
Days to Decision 24 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
86d faster than avg
Panel avg: 110d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 485
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K992589.
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