Cleared Traditional

K971647 - LL BI-FOCAL, DAILY WEAR CONTACT LENS

K971647 is an FDA 510(k) clearance for LL BI-FOCAL, manufactured by Lombart Lenses, Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971647 · Lombart Lenses, Ltd. · Ophthalmic device
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Jul 1997
Decision
71d
Days
Class 2
Risk

K971647 is an FDA 510(k) clearance for the LL BI-FOCAL, DAILY WEAR CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Lombart Lenses, Ltd. (Norfolk, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 71 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 Lombart Lenses, Ltd. devices

FDA 510(k) Submission Details - K971647

510(k) Number K971647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1997
Decision Date July 15, 1997
Days to Decision 71 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
39d faster than avg
Panel avg: 110d · This submission: 71d
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 K971647.
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · Aspect Vision Care, Ltd. · Aug 1997
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS
K972303 · Ocular Sciences Puerto Rico, Inc. · Aug 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454 · Bausch & Lomb, Inc. · Aug 1997
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
K971049 · Aspect Vision Care, Ltd. · May 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K971164 · Aspect Vision Care, Ltd. · May 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)
K971515 · Biomed Devices Corp. · May 1997