Cleared Traditional

K982904 - ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS

K982904 is an FDA 510(k) clearance for ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HI..., manufactured by Les Laboratoires Blanchard. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K982904 · Les Laboratoires Blanchard · Ophthalmic device
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Sep 1998
Decision
14d
Days
Class 2
Risk

K982904 is an FDA 510(k) clearance for the ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTAC.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Les Laboratoires Blanchard (Chicago, US). The FDA issued a Cleared decision on September 1, 1998 after a review of 14 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 Les Laboratoires Blanchard devices

FDA 510(k) Submission Details - K982904

510(k) Number K982904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1998
Decision Date September 01, 1998
Days to Decision 14 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
96d faster than avg
Panel avg: 110d · This submission: 14d
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 279
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K982904.
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
K982110 · Optech, Inc. · Nov 1998
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)
K983053 · Alden Optical Labs., Inc. · Oct 1998
SOFT (HYDROPHILIC) CONTACT LENSES
K982774 · Cl-Tinters · Sep 1998
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
K974837 · Igel Vision Care Pte , Ltd. · Jul 1998
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT
K981779 · Cantor & Silver , Ltd. · Jun 1998
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
K981252 · Alden Optical Labs., Inc. · Jun 1998