Cleared Traditional

K973847 - AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS

K973847 is an FDA 510(k) clearance for AL-47 TORIC (ISOFILCON) SOFT (TORIC) DA..., 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 61-day FDA review.

K973847 · Martin Dalsing · Ophthalmic device
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Dec 1997
Decision
61d
Days
Class 2
Risk

K973847 is an FDA 510(k) clearance for the AL-47 TORIC (ISOFILCON) SOFT (TORIC) 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 December 8, 1997 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.

View all Martin Dalsing devices

FDA 510(k) Submission Details - K973847

510(k) Number K973847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1997
Decision Date December 08, 1997
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
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 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K973847.
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
K980649 · CooperVision, Inc. · May 1998
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K974780 · Bausch & Lomb, Inc. · Mar 1998
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · CooperVision, Inc. · 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
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
K973597 · Martin Dalsing · Nov 1997