Cleared Traditional

K945981 - LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS

K945981 is an FDA 510(k) clearance for LIFESTYLE 55 (METHAFILCON A) SOFT HYDRO..., 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 61-day FDA review.

K945981 · Permeable Technologies, Inc. · Ophthalmic device
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Feb 1995
Decision
61d
Days
Class 2
Risk

K945981 is an FDA 510(k) clearance for the LIFESTYLE 55 (METHAFILCON A) 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 February 7, 1995 after a review of 61 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 - K945981

510(k) Number K945981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1994
Decision Date February 07, 1995
Days to Decision 61 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
49d faster than avg
Panel avg: 110d · This submission: 61d
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 K945981.
DELTA
K943178 · Venture Management Corp. · Apr 1995
ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K951180 · Szabocsik and Assoc. · Apr 1995
HORIZON 55 BI-CON TORIC
K950818 · Westcon Contact Lens Co., Inc. · Mar 1995
LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS
K950283 · Permeable Technologies, Inc. · Feb 1995
PRECISION UV(TM) (VASURFICON A)
K946012 · Pilkington Barnes-Hind, Ltd. · Jan 1995
HORIZON 55 BI-CON
K945365 · Westcon Contact Lens Co., Inc. · Dec 1994
K945981 · LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS
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