Cleared Traditional

K942494 - LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS

K942494 is an FDA 510(k) clearance for LIFESTYLE MULTIVUE-S (POLYMACON) SOFT H..., manufactured by Permeable Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K942494 · Permeable Technologies, Inc. · Ophthalmic device
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Sep 1994
Decision
106d
Days
Class 2
Risk

K942494 is an FDA 510(k) clearance for the LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Permeable Technologies, Inc. (Morganville, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K942494

510(k) Number K942494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date September 08, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
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 K942494.
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · Bausch & Lomb, Inc. · Dec 1994
OCU-FLEX-38 (POLYMACON)
K941998 · Ocu-Ease Optical Products, Inc. · Oct 1994
PRECISION UV(TM) (VASURFILCON A)
K944722 · Pilkington Barnes-Hind, Ltd. · Oct 1994
CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES
K943490 · Continental Soft Lens, Inc. · Aug 1994
ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS
K942302 · Preferred Optics, Inc. · Aug 1994
ESSTECH PS ASPHERIC
K942186 · Szabocsik and Assoc. · Jul 1994
K942494 · LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS
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