Cleared Traditional

K942372 - SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS

K942372 is an FDA 510(k) clearance for SIMULVUE 38 (POLYMACON) SOFT (HYDROPHIL..., manufactured by Unilens Corp., USA. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K942372 · Unilens Corp., USA · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
50d
Days
Class 2
Risk

K942372 is an FDA 510(k) clearance for the SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unilens Corp., USA (Largo, US). The FDA issued a Cleared decision on July 7, 1994 after a review of 50 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.

FDA 510(k) Submission Details - K942372

510(k) Number K942372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1994
Decision Date July 07, 1994
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K942372.
ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K942187 · Szabocsik and Assoc. · Jul 1994
H55 HYDROPHILIC CONTACT LENS
K942214 · Martin S. Knopf Assoc., Inc. · Jul 1994
UNILENS 38 SOFT ASPHERIC CONTACT LENS
K941836 · Unilens Corp., USA · Jul 1994
LL-55 (METHAFILCON A) FOR DAILY WEAR
K941877 · Lombart Lenses, Ltd. · Jun 1994
DAILY WEAR SOFT CONTACT LENSES
K941484 · Ciba Vision Corporation · Jun 1994
UCL MULTIFOCAL SOFT CONTACT LENS
K941607 · United Contact Lens, Inc. · Jun 1994
K942372 · SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS
Download PDF FDA Summary Unilens Corp., USA