Cleared Traditional

K943490 - CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES

K943490 is an FDA 510(k) clearance for CONTINENTAL 45 (HEFILCON A) SPHERICAL &..., manufactured by Continental Soft Lens, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K943490 · Continental Soft Lens, Inc. · Ophthalmic device
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Aug 1994
Decision
23d
Days
Class 2
Risk

K943490 is an FDA 510(k) clearance for the CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Continental Soft Lens, Inc. (Littleton, US). The FDA issued a Cleared decision on August 11, 1994 after a review of 23 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 Continental Soft Lens, Inc. devices

FDA 510(k) Submission Details - K943490

510(k) Number K943490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date August 11, 1994
Days to Decision 23 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 110d · This submission: 23d
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 280
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K943490.
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · CooperVision, Inc. · Nov 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · CooperVision, Inc. · Jul 1995
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · Bausch & Lomb, Inc. · Dec 1994
DAILY WEAR SOFT CONTACT LENSES
K941484 · Ciba Vision Corporation · Jun 1994
BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
K941370 · Bausch & Lomb, Inc. · May 1994