Cleared Traditional

K992466 - OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR

K992466 is an FDA 510(k) clearance for OCU-FLEX-38 KERATOCONUS (POLYMACON) SOF..., manufactured by Ocu-Ease Optical Products, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K992466 · Ocu-Ease Optical Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
73d
Days
Class 2
Risk

K992466 is an FDA 510(k) clearance for the OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Ocu-Ease Optical Products, Inc. (Pinole, US). The FDA issued a Cleared decision on October 4, 1999 after a review of 73 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 Ocu-Ease Optical Products, Inc. devices

FDA 510(k) Submission Details - K992466

510(k) Number K992466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date October 04, 1999
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 110d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

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 278
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K992466.
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
K992950 · Prosthetic Soft Lens Corp. · Nov 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
K991015 · Lamda Polytech , Ltd. · Nov 1999
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K992692 · Benz Research and Development Corp. · Oct 1999
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY
K992589 · Opti-Centre Laboratories · Aug 1999
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
K992500 · Cantor & Silver , Ltd. · Aug 1999
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
K992339 · Colorsoft Laboratories Corp. · Aug 1999