Cleared Traditional

K973597 - AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS

K973597 is an FDA 510(k) clearance for AL-47 (ISOFILCON) SOFT (SPHERICAL) DAIL..., manufactured by Martin Dalsing. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K973597 · Martin Dalsing · Ophthalmic device
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Nov 1997
Decision
59d
Days
Class 2
Risk

K973597 is an FDA 510(k) clearance for the AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Martin Dalsing (Grand Junction, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 59 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 Martin Dalsing devices

FDA 510(k) Submission Details - K973597

510(k) Number K973597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date November 20, 1997
Days to Decision 59 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
51d faster than avg
Panel avg: 110d · This submission: 59d
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 K973597.
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
K973847 · Martin Dalsing · Dec 1997
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)
K973967 · Alden Optical Labs., Inc. · Dec 1997
FLEXLENS, FLEXLENS TORIC
K973192 · Specialty Ultravision, Inc. · Nov 1997
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI
K972807 · Benz Research and Development Corp. · Oct 1997
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