Cleared Traditional

K965012 - LIFESTYLE BREAK THRU (POLYMACON)

K965012 is an FDA 510(k) clearance for LIFESTYLE BREAK THRU (POLYMACON), manufactured by The Lifestyle Co., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K965012 · The Lifestyle Co., Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
85d
Days
Class 2
Risk

K965012 is an FDA 510(k) clearance for the LIFESTYLE BREAK THRU (POLYMACON). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by The Lifestyle Co., Inc. (Morganville, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 85 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 The Lifestyle Co., Inc. devices

FDA 510(k) Submission Details - K965012

510(k) Number K965012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date March 11, 1997
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
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 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K965012.
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
K970019 · Menicon U.S.A., Inc. · Mar 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · Biomed Devices Corp. · Mar 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
K964902 · Metro Optics of Austin, Inc. · Mar 1997
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT
K964528 · Benz Research and Development Corp. · Mar 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · Sunsoft Corp. · Feb 1997
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
K964612 · Vistakon, Johnson & Johnson Vision Products, Inc. · Jan 1997